Clinical Research Group New Employee Orientation

Clinical Research Group

New Employee Orientation

Welcome Aboard

Welcome to Drexel University College of Medicine and The

Clinical Research Group!We are delighted to welcome you to the Drexel University College

of Medicine, Clinical Research Group New Employee Orientation.

Please enjoy a walk with us, through our journey of how we started and who

we are; what we do; who our partners are and all available resources that we

would like to share with you, including services of the University that may

prove to be useful for both you and any prospective employees.

Message from the Vice Dean for Research:Kenny J. Simansky, Ph.D.

Drexel University College Of Medicine, Vice Dean for Research

The nature of research activity in a medical school defines the intellectual climate of the institution. Experimental investigation of the mechanisms and consequences of disease and trauma provides insight for developing novel strategies to maintain wellness and treat sickness. Systematic evaluation of those strategies—changes in lifestyle; new pharmacological, molecular and other manipulations of cellular targets; new implanted sensors, artificial tissues and devices—establishes which to adopt for clinical practice and which to discard.

This entire research enterprise should and must create the culture in which students are taught medicine as a rational, evidence-based approach to improving human health. We are proud of the internationally recognized research programs conducted by our basic scientists and of the many complementary efforts in clinical science and clinical care conducted by our faculty. Our Clinical Research Group provides the foundation for testing new treatments in carefully supervised trials in our patients.

Message from the Vice Dean for ResearchKenny J. Simansky, Ph.D.


Translating biomedical discoveries from the wet laboratory to the bedside defines a great academic medical center and is the primary emphasis of the National Institutes of Health. Thus, Drexel University College of Medicine will be investing significant resources in expanding our translational and clinical research programs during the next five years.

Drexel Medicine’s Strategic Plan for 2007-2012 includes initiatives that emerged from existing strengths in research on the mechanisms, prevention and treatment of chronic pain; autism and autism spectrum disorders; viral, protozoal (malarial) and other infectious diseases; and inflammation and its relationship to the development of cancer. Of course, our strengths and successes in research extend beyond those areas, and I invite you to explore the web pages of our departments, institutes and centers. In addition, interactions with faculty from other schools and colleges of Drexel University will continue strategic developments in neuroengineering and other areas of bioengineering.

These initiatives will apply our leadership in technology to assisting recovery of patients suffering from trauma and diseases of the nervous system and to the healing promised by emerging methods of regenerative medicine. Our institution has a special history of educating women physicians and scientists for more than 150 years. This tradition is highlighted now in the form of the Institute for Women’s Health and Leadership. Thus, we are particularly excited by our plans to expand our scientific efforts in women’s health and in gender-based biomedical research. In collaboration with our colleagues from Information Science and Technology, Nursing, and Public Health, we will be applying biomedical informatics, health informatics and epidemiology to identifying new areas for scientific investigation and for optimizing clinical care. Overall, we look forward enthusiastically to continuing to grow and diversify our programs of scientific discovery towards better serving our patients in the future.

Message from the Vice Dean for ResearchKenny J. Simansky, Ph.D.


A Message from the Chief Operating Officer,

Clinical Research Group – Donna J. Walsh, RN, BSN, MS, CIP,

CCRC Welcome to the Clinical Research Group. Clinical trials

are studies that are sponsored or supported by a private company and involve an evaluation of a drug, device or technology. These studies include Phase I through IV human research. Drexel Medicine and/or its affiliated hospitals serve as a site and/or the sponsor in these studies.

We are committed to serving three groups of clients – the public, industry, and our researchers and staff. Whether you are interested in learning about or participating in a clinical trial . . . or you are interested in Drexel Medicine or its affiliate hospitals as a research site for your next clinical trial . . . or you are a researcher or staff member at Drexel Medicine or one of its affiliated hospitals looking to start or manage your clinical trial – you have come to the right place!

Meet the Office Of Research Management Team

• Kenny J. Simansky, PhDVice Dean for ResearchNew College Building, 19116Phone: (215) 762-8949Email: [email protected]

Dr. Kenny Simansky is the Vice Dean for Research. Simansky provides leadership and strategic planning as related to basic and clinical research activities.

mailto:[email protected]


• Noreen M. Robertson, DMDDirector of Research Program DevelopmentNew College Building, 11301Phone: (215) 762-4889Email: [email protected]

Dr. Noreen Robertson is the Director of Research Program Development. Robertson provides direction and fosters research in collaborative, interdisciplinary research programs as related to basic and clinical.



• Donna J. Walsh, RN, BSN, MS, CIP, CCRCChief Operating Officer, Clinical Research Operations3 Parkway Building, 10th Floor, Suite 1000Phone: (215) 255-7803Email: [email protected]

Donna Walsh is the Chief Operating Officer of Clinical Research Operations and the Clinical Research Group (CRG). Ms. Walsh provides leadership and is responsible for all infrastructural support and oversight of clinical trials within the College of Medicine.



• Richard Huneke, DVMExecutive Director of University Laboratory Animal Resources (ULAR)Phone: (215) 762-7970Email: [email protected]

Dr. Richard Huneke is Executive Director of ULAR. Huneke directs the critical mission of housing laboratory animals for research and providing care that meets the highest veterinary standards for good clinical practice and the regulations of accrediting agencies and governmental authorities.



• Lauren E. MaySenior CoordinatorNew College Building, 19118Phone: (215) 762-8961Email: [email protected]

Lauren May is the Senior Coordinator. Ms. May coordinates the processes required to develop and foster research activities.



• Danyelle P. BlackwellExecutive AssistantNew College Building, 19th FloorPhone: (215) 762-8949Email: [email protected]

Danyelle Blackwell is the Executive Assistant to the Vice Dean for Research.


Clinical Research Group (CRG) - An Overview

Who We Are Drexel University College of Medicine is committed to

supporting and facilitating clinical research, and recognizes that industry plays a significant role in the discovery of new and better medical treatment.

The Clinical Research Group (CRG) was created to provide a one-stop service to facilitate clinical trial management. CRG consists of administrative, clinical, financial, legal and regulatory professionals, who work as a team to smoothly and efficiently establish clinical trials at the College of Medicine and its many affiliated hospitals. Whether you are a small entity or a large one, CRG strives to create a strong working relationship that supports not only current clinical trials, but also future trials.


Who We Are

Our Mission: Established in 2003, the Clinical Research Group`s

mission is to enable Drexel University College of Medicine (DUCOM) to achieve an environment of research excellence, by supplying a supportive infrastructure, developing sound business practices, and fostering a culture of innovation in our research activities.


Who We Are

Our Advantages: • World-class health-care centers in Eastern Pennsylvania,

New Jersey and counting • Experienced investigators and coordinators with many

years of service • Use of Western Institutional Review Board (IRB) for

industry-sponsored clinical trials • Centralized office to fostering industry-sponsored research

at more than one research site • Stable patient population


What We Do

Our Services:CRG is dedicated to assisting in placing and conducting a

clinical trial at DrexelUniversity College of Medicine. A partial list of our services

includes:• Conducting training seminars for DUCOM's Clinical

Investigators and Coordinators in Good Clinical Practices (GCP)

• Operating with standards of process and policy, by providing a one-top resource, assisting Investigators and sponsors with implementation and administrative services in clinical studies

• Managing oversight to clinical sites and providing recruitment strategies

• Providing public awareness to the benefits of participating in clinical trial research


What We Do

Our Services continued:• Leading teams of highly skilled Research

Investigator/Coordinator Professionals, by providing a platform in which to enhance knowledge of process through presentations and mentorship

• Implementing a multi-disciplinary approach to assessing high risk research and its impact to the University

• Accessing analytical support and clinical trial database/metrics • Negotiating and developing study contracts and budget

processes• Collaborating with Drexel University and their international

reputation for technology, by offering services to enhance our translational capabilities in clinical trials

• Expanding DUCOM's research relations with affiliate sites and community partners

Meet the TeamClinical Research Group (CRG)

Operations:Donna J. WalshChief Operating Officer, Clinical Research

Operations(215) [email protected]

Theresa M. PiechowskiResearch Program Administrator(215) [email protected]

Adam FuhrerResearch Administrative Assistant(215) [email protected]

Legal/Contract/Budget: Priya SankarAssistant General CounselAssociate Director, Contracts and Budget(215) [email protected]

Stephanie PetersonContract Specialist(215) 255-7805 [email protected]

Legal/Contract/Budget (cont.): Anna WongSenior Financial Analyst(215) [email protected]

Douglas LivolsiFinancial Coordinator(215) [email protected]

Sally EellsFinancial Coordinator(215) [email protected]

Research Management – Affiliate Sites:Esther NkrumahAssistant Director, Clinical Research ManagementSt. Peter’s University Hospital, New Brunswick, NJ(732)745-8600 [email protected]










Meet the TeamClinical Research Group (CRG)

Clinical:Elizabeth ConnorSenior Clinical Research Nurse Coordinator(215) [email protected]

Andrew FrancisClinical Research Nurse Manager I – HUH- St. Christopher Children`s Hospital(215) 427-5360; (215)[email protected]

Marjorie HeplerClinical Research Nurse Manager I – HUH-

PPP(215)2 [email protected]

Anne JohnsonResearch Nurse Coordinator(215) [email protected]

David PhuongClinical Research Nurse Coordinator II(215) [email protected]

Clinical continued:Karen SkinnerClinical Research Nurse coordinator III(215)[email protected]

Josh ZigmontData Coordinator(215) [email protected]

Research Management/Training and Development:

Dr. Marcellina OparaojiAssociate Director, Clinical Research Management &

Training(215) [email protected]

Clinical Research Group Location:1601 Cherry Street, Mail Stop 1010213 Parkway Building, 10th Floor Suite 1000Philadelphia, PA 19102Phone: 215-255-7879Fax: 215-255-7885

Clinical Research Group Organizational Chart

Who we work with – CRG partners

CRG helps coordinate clinical research operations in the following areas and more, within DUCOM:

1)Clinical Departments2)Administrative Departments3)Institutes4)Centers


Clinical Departments: DUCOM

• Anesthesiology • Cardiothoracic Surgery • Dermatology • Emergency Medicine • Endocrinology• Hematology/Oncology• Infectious Diseases & HIV

Medicine• Family, Community and

Preventive Medicine • Medicine • Neurology

• Obstetrics and Gynecology • Ophthalmology • Orthopedic Surgery • Otolaryngology • Pathology and Laboratory

Medicine • Pediatrics • Psychiatry • Radiation Oncology • Radiologic Sciences • Surgery • Women’s Health


DUCOM Centers:• Adult Cystic Fibrosis Center • Center for Study of Hospital-Acquired Infection • Drexel Autism Center • Memory Disorders Center • National Institute on Drug Abuse Center of Excellence • Center for Molecular Diagnostics and Genome Research• Drexel Center for Women’s Health


Office of Regulatory Research Committees ORRC)(IRB/WIRB)

Ensures the protection of human subjects through:

• Responsible for providing protocol review and approval• Continuing review of regulatory documentation • Compliance with federal guidelines• Proper reporting of study related adverse events and

injury• Human Subject protection through voluntary consentLocation: Office of Regulatory Research Committees 1601 Cherry Street, 3 Parkway Bldg., Suite 10-

444 Philadelphia, PA. 19102

Phone Number(s): 215-255-7857 Fax: 215-255-7874


Office of Research Compliance & Administration (ORCA)

The Office of Research Compliance and Administration is dedicated to

enhancing University research and sponsored activity by providing excellent support

services to our faculty.

ORCA Responsibility Areas:• Assist in non-technical project conceptualization and planning• Provide general guidelines and interpretation for proposal preparation and

award administration• Review, approve and submit all sponsored project proposals on behalf of the

University• Negotiate and accept sponsored awards; Negotiate subcontracts to other

institutions• Establish sponsored project cost centers, monitor performance, assist in

compliance review of spending in accordance with University and sponsor policies and procedures and OMB Circulars A-21 and A-110, and assist Principal Investigators in the financial closeout of the project


Office of Research Compliance & Administration (ORCA)(contd)

• Interpret federal, University and sponsor regulations, policies and guidelines• Prepare invoices and financial reports; Collect cash• Maintain proposal and award database and prepare management reports;

Provide training and support for faculty and staff during the sponsored project life cycle

• Coordinate and facilitate audits• Monitor programmatic and financial compliance

Every University Department has an ORCA Program Administrator (PA) who manages the

processes listed above. The list of PA’s by department can be found on the ORCA website

by clicking “Proposal Submission” then “Contacts.”

Located at: 3201 Arch Street, Suite 100, Drexel University Main Campus Philadelphia, PA, 19104

Phone Number(s): 215-895-5849 Fax: 215-895-6699


Investigational Drug Research Pharmacy

The drug research pharmacist has an integral part in drug research studies.

• The research coordinator will work alongside the pharmacist to fabricate a budget for utilizing pharmacy services

• Pharmacy is responsible for drug storage and accountability• Mixing and dispensing of drug the responsibility of

pharmacist • If subject is to be discharged on study medication, the

research pharmacist is to be contact

Located at: Hahnemann Hospital, Basement, North Tower, Denise Lai Tomako, Pharm. D

Phone Number(s): 215-762-1140


Hahnemann Laboratory ServicesAn important resource for research coordinators who are conducting studies

whichrequire lab samples and/or lab equipment.

Hahnemann University Laboratory Services• Assist in obtaining CLIA and CAP for coordinators• Assists in obtaining lab value ranges for Hahnemann University

Hospital• Assist in obtaining coordinators access into Sunquest system for

lab values• Assist with price negotiations for research laboratory services and

laboratory equipment rental

Located at: Hahnemann Hospital, 5th Floor, North TowerPhone Number(s): 215-762-7596


Cashier's Office:

This office assist with procurement of subject reimbursement funds.

• Provides petty cash for study related payments• Open Monday-Friday from 9am-5pm

Located at: Hahnemann Hospital , 1st Floor, North Tower (lobby)

Phone Number(s): 215-762-8480


Research Committee College of Medicine:Established under the existing Bylaws of the College of

Medicine,the Research Committee serves as the premier body of faculty, which provides required oversight for the development and

implementation of strategic growth initiatives in research and graduate education missions.

Membership is composed of one member of each Department of the Drexel University College of Medicine. Members are appointed for a term of four (4) years, with staggered terms to permit replacement of approximately twenty- five percent (25%) of the Committee each year. The following serve as permanent ex-officio members of this Committee, without vote: Directors of Centers and Institutes, Legal Counsel.


Research Committee College of Medicine continued:Committee Chairmanship: The Research Committee is chaired by the Associate/Vice Dean for Research, Drexel University College of Medicine – Dr. Kenny Simansky

Meetings are held every second Friday of the month at 8:00 a.m. in the Board Room, NCB. Except for the regular members, attendance is by invitation only.


Research Committee College of Medicine:Responsibilities of the Committee include serving as a primary

advisory group to the Dean on matters relating to research. • The Committee reviews, periodically, the effectiveness with

which the broad research objectives of the Drexel University are being achieved and will report their recommendations to the Dean

• The Committee helps coordinate information regarding equipment that can be utilized cooperatively for research efforts

• The Committee recommends the development of specific institutional resources and facilities as they apply to research

• The Committee recommends guidelines and procedures for utilizing institutional resources for research

• The Committee advises the Dean regarding the allocation of institutional research support grants for specific projects


DUCOM Institute for Women's Health and Leadership:The Institute (IWHL) and its core programs in leadership, education, research, outreach/advocacy, and the Archives and Special Collections are co-located in a new wing bearing the Institute’s name on the Queen Lane campus of the medical school.

IWHL is perceived as an essential component of the College of Medicine, as indispensable as the Departments of Medicine, Ob/Gyn and Pediatrics, and continues to be a catalyst for collaboration in women’s health and leadership within DUCOM, across Drexel University and in the Philadelphia community, regionally and nationally.

The Center for Women’s Health Research is fully operational under the leadership of a renowned researcher and is bringing national recognition to Drexel for its trailblazing agenda.


DUCOM Institute for Women's Health and Leadership:Named in 1996 by the U.S. Department of Health and Human Services as a National Center of Excellence in Women's Health, one of only six such designations in the nation at the time, the Institute has set its professional sights on developing resources and programs that will bridge the gaps in women's health and leadership.

The Institute for Women's Health and Leadership, with its roots in a century and a half of tradition, is defining its worth through a determination to make history, not just record it.


Institute for Molecular Medicine and Infectious Disease:The Drexel University College of Medicine Institute for Molecular Medicine and Infectious Disease is a collaborative, inter-campus enterprise focused on research, diagnosis, treatment, prevention, and clinical management of infectious disease, cancer, and metabolic and genetic disorders.

The Institute facilitates the development and expansion of 14 Research Centers of Excellence (RCEs) and 2 Administrative Centers. In parallel with this objective, the Institute facilitates the training and development of graduate students, postdoctoral fellows, residents and junior faculty.


Institute for Molecular Medicine and Infectious Disease:The Institute also provides an organized framework to guide the development of inter-campus, inter-college, and inter-unit research initiatives across the University, stimulating functional interactions across the basic and clinical science boundaries and increasing the extent and quality of these interactions.

The Institute strives to enhance visibility of Drexel University and interactions of the University with other academic, industrial and governmental organizations at the regional, national, and international levels with respect to research concerning the treatment and prevention of human disease.


Drexel Institute for Biotechnology and Virology Research:The Drexel Institute for Biotechnology and Virology Research (DIBVR) is a new research division, established in July 2004 by Drexel University College of Medicine, and is the result of an innovative academic partnership between Drexel University and the Hepatitis B Foundation, a national nonprofit research organization.

DIBVR faculty share space and resources with the Hepatitis B Foundation and its research institute in the 62,000 square foot Pennsylvania Biotechnology Center located in Doylestown, PA.


Office of Entrepreneurship and Technology Commercialization

• Works with faculty and staff to identify technologies with commercial potential

• Files patents and copyrights to protect technologies• Works with companies, entrepreneurs and investors to

license technologies and bring them to market

Located at: the Laurence A. Baiada Center on Arch Street between 32nd and 33rd, across from Buckley Field


Office of the General Counsel:• The Office of the General Counsel is the College’s lawyers.

This office provides legal services to support the College’s initiatives, missions and operations.

• Their services include – litigation and risk management– contract negotiation, drafting and review– legal and regulatory compliance– legal advice and counsel in business transactions, labor

and employment, real estate, intellectual property and technology transfer matters, and other matters impacting institutions of higher education


Office of the General Counsel:

The Office of the General Counsel provides legal counsel to DUCOM trustees, officers and employees with regard to legal matters affecting the College.

Note that the OGC cannot provide legal advice or representation to individual members of the University community in connection with matters against the University or with other personal matters.


Office of the General Counsel:The Office of the General Counsel provides the following legal services with regard to clinical research:•Counsels all research administrative offices (Office of the Vice Dean for Research, CRG, ORRC and ORCA) in the following:

– Conflicts of interest in research– Research misconduct and noncompliance– Protecting the College’s Intellectual Property– HIPAA and other privacy issues affecting patients and Study subjects– Any other legal issues affecting research

•Reviews and negotiates all agreements in connection with research. Thus, you should not negotiate or sign any research agreements without legal counsel•Serves as an ex officio member on the IRB

Located at: 1601 Cherry Street, 3 Parkway Building Suite 10627 Philadelphia, PA 19102 Phone: 215-255-7835 Fax: 215-255-7856


Corporate Compliance and Privacy Office:

What is the Compliance and Privacy Program and why does it exist?

The Corporate Compliance and Privacy Program is a College of Medicine program designed to ensure regulatory compliance and patient privacy rights as everyone works to satisfy the College's nonprofit teaching, research and healthcare delivery missions.


Compliance Hotline :

The following telephone number or web-link may be used to report any improper

conduct:• College of Medicine/Health Sciences toll free: 866-936-1010 • Web-site reporting: click "Make a Report"• Every call or web report is kept completely confidential. No

information likely to reveal your identity will be shared with anyone else without your permission. Callers will be completely protected from retaliation for having made good faith reports


Compliance Hotline continued:

• If you are aware of any conduct - act or omission - which you think violates the law, College or University policy, rule or regulation, you are urged to report them to your supervisor, your Department Head, your Dean, or a Vice President, or to use the hotline

• Questions about the University's Code of Conduct or the hotline may be addressed either to the College of Medicine Chief Compliance and Privacy Officer, Edward G. Longazel, at [email protected] or to the University's Vice President and General Counsel, Michael J. Exler, at [email protected]


What are the functions of the Corporate Compliance and Privacy Office and staff?

The staff of the Corporate Compliance and Privacy Office manage the day-to-day operations of the Compliance and Privacy programs providing the following services:

• Training • Education • Regulatory research • Auditing, monitoring and

investigations

• Coding analysis • Encounter form review • Screening for federal

program exclusion • Electronic Medical Record

(EMR) access approval, auditing and monitoring

• Research protocol reviews for HIPAA issues

• Monitor and manage the Hotline

• Report quarterly to the Audit Committee of the Board of Directors (PHEC)


The Office of Equality and Diversity (OED):• OED is committed to promoting, supporting and providing

resources to sustain a living, learning and working environment of diversity, equality, fairness, inclusion and respect where all members of the University community are valued

• OED is responsible for ensuring that the University complies with its own policies and with federal, state and local laws prohibiting discrimination and harassment based upon race; color; religion; gender; pregnancy; national origin; age; disability; sexual orientation, gender identity and expression; and veteran status

• In addition to investigating complaints, OED utilizes various conflict resolution processes to address complaints of discrimination, harassment and retaliation


The Office of Equality and Diversity (OED):To further uphold its mission, the Office of Equality & Diversity offers the following training and educational opportunities:

Training:Without Regard is a mandatory discrimination, harassment and retaliation prevention training program for all faculty and staff.

Workshops:Several workshops are offered by request on a range of topics, such as:

• Discrimination, Harassment and Retaliation Prevention • Diversity Recruitment and Hiring Practices • Diversity and Inclusion• Conflict Resolution Skills Located at: 3201 Arch Street, Suite 210, Philadelphia, PA 19104

Phone: 215-895-1403 Email: [email protected]


Academic Publishing Services (APS):APS provides professional, editorial assistance for DUCOM faculty,

residents, and postdoctoral fellows, especially for first-time authors preparing

a paper for publication: Services APS provides:• Document editing and proofreading • Journal-specific submission requirements profile • Book project management • Reference formatting • Permission requests to use copyrighted material • Illustration preparation assistance • On-line manuscript submission and Publisher communication• Helps publishers eliminate language and formatting errors that

distract reviewers • Costs nothing!


Communications and Marketing:Mission:The Office of Communications and Marketing raises awareness for

Drexel University College of Medicine through the strategic use of

external and internal communications, fundraising and special events. They are

an award-winning staff dedicated to providing services to their colleagues

and the public.

They strive to concentrate their creative energy on the greatest opportunities, tackling most projects with a team-approach that

draws from the individual strengths of the staff.


Communications and Marketing:Services rendered: • Media relations | Media Relations Policy • Public relations • Marketing • Special events | Black Tie White Coat Ball | Golf Outing • Internal and external communications | Brand Identity

Manual • Web content management | Web Style Guide• News releases • Newspager • Drexel Medcast® • Drexel Med Monitor • Strategy for the Future • 10-Year report


Communications and Marketing:• Main phone: 215-255-7330

• Media calls: 215-255-7328

• Marketing: 215-255-7333

• Newspager: 215-255-7329

• Website: 215-255-7334

• Events: 215-255-7327

• Fax: 215-255-7301


DUCOM Human Resources:Mission: Enable increased faculty, staff and student engagement

through a human capital approach that attracts, rewards, develops and retains

diverse, quality talent.For HR questions and/or requests, we suggest you contact the

following:• Benefits Administration:

Questions regarding your employee benefits administered by HR.Note: for Dragon Plan questions, please call the Benefits Service Center at 866-806-0950

• Recruitment / Employee Relations:Questions related to submitted recruitment forms; Dept Mgrs requesting to post student positions online; or employee issues that may require private considerations.


DUCOM Human Resources: Performance Appraisal

• Communication: Expresses verbal and written ideas and thoughts clearly and effectively; good listening and comprehension skills; keeps others adequately informed; uses appropriate communication methods

• Teamwork/Cooperation: Works effectively with others; establishes and sustains a positive impact on people; actively contributes to teamwork; balances team and individual responsibilities; exhibits objectivity and openness to other`s views

• Adaptability/Flexibility: Adapts to changes in the work environment; manages competing demands; accepts criticism and feedback; adjusts approach or method to best fit the task


DUCOM Human Resources: Performance Appraisal• Job/Technical Knowledge:

Demonstrates skills and technical competence needed to execute job duties; able to learn and apply new skills; keeps up with current developments; understands how job relates to others; uses resources effectively

• Initiative: Seeks solutions to problems both within and beyond area of direct responsibility; looks for and takes advantage of opportunities; seeks opportunities to increase job skills and knowledge

• Dependability: Arrives as scheduled, prepared to work; takes responsibility for own actions; commits to doing the best job possible; keeps commitments

• Customer Service: Understands the service needs of students, patients and/or co-workers and regularly meets or exceeds them; confirms satisfaction with the customers s/he serves; continually seeks to enhance/improve the interactions and processes that influence the satisfaction of those customers; solicits customer feedback to improve service


DUCOM Human Resources:Performance Appraisal: Staff Annual Performance

Evaluations To initiate a new staff evaluation, access the online

performance managementsystem by logging in to DrexelOne and following these steps:• Log in to DrexelOne • Select the Employees tab • Select BannerWeb Services for College of Medicine

Employees • Select Employee Information • Select Performance Management


DUCOM Human Resources:Performance Appraisal: Staff Annual Performance

Evaluations • Please make sure that pop-ups are enabled. If you select

the Performance Management link and only see a blank screen, use the following instructions to enable the pop-ups:– Click on the bar that appears under the URL field on the browser and

select Always Allow Pop-ups from this Site – Select the Performance Management link again– If you have the Google toolbar, select the (1)Pop-ups block icon in the

toolbar. Select the Performance Management link again

The annual Performance Management process can be found on the HR website.


• Request a call back from a HR Representative: For questions not related to any of the above categories

Located at: 3201 Arch St. Suite 430

Phone: 215-895-2850 Fax: 215-895-5813 Email: Click 'Ask HR' feature

Academic and Research Affiliates

Drexel College Of Medicine (DUCOM)

• Drexel University College of Medicine, a new name just a few years ago, is the consolidation of two venerable medical schools with rich and intertwined histories: Hahnemann Medical College and Woman’s Medical College of Pennsylvania. Established in 1848 and 1850, respectively, they were two of the earliest medical colleges in the United States, while Woman’s was the very first medical school for women in the world

• Today, with over 1,000 medical students, Drexel University College of Medicine (DUCOM) has the largest medical student enrollment of any private medical school in the nation, even educating more than 500 graduate students. The College is also the academic partner in education of some 550 medical residents. There are more than 700 clinical and basic science faculty, and more than 1,700 affiliate and volunteer faculty


Drexel College Of Medicine (DUCOM) • The College of Medicine's main campus, Queen Lane, is in a

suburban-like setting in the East Falls section of Philadelphia. Additional facilities are located at the Center City campus, which includes Hahnemann University Hospital. Our Pediatrics Department is at St. Christopher’s Hospital for Children, and our Psychiatry Department is based at Friends Hospital. Students can receive clinical education at 25 affiliated hospitals and ambulatory sites chosen for commitment to teaching as well as medical excellence

• DUCOM's clinical practice, Drexel University Physicians®, is a patient-focused practice emphasizing quality, innovation and community service, and enhanced by physician involvement in the research and educational programs


Drexel College Of Medicine (DUCOM)

Since Drexel University College of Medicine does not own its own hospital, it has partnered with area hospitals and health facilities to achieve its academic and research missions. The following slides identify DUCOM`s affiliated hospitals.


Friends Hospital

• Located on a 100-acre campus in Northeast Philadelphia • Inpatient facility with 24-hour nursing care in all units • Crisis Response Center provides evaluations and admissions

24 hours a day, 7 days a week• Children and Adolescent Services offers a range of

inpatient hospital services for children and adolescents suffering from behavioral and emotional problems

• Inpatient hospital services: For ages 5-12 (children) and 13 -18 (adolescents)

• Eating Disorders Program: Helping children and adolescents, ages 13+, with anorexia, bulimia, and binge eating disorder through inpatient services for both males and females

• Adult Services: An inpatient program for adults ages 18 to 65


Friends Hospital

• Older Adult Services: The first program in the Delaware Valley specifically designed for elderly with a mental illness

• Inpatient treatment: For individuals with anxiety disorders, depression, other affective disorders, schizophrenia and chronic mental disorders, personality disorders, or any other mental or emotional disorder

• The Greystone Program: Providing long-term residential services for persons with severe and persistent mental illness

• The Women's Program: Offering psychiatric and psychological services through an inpatient program specifically designed for women

• Dual Diagnosis Program: Designed for patients with a primary psychiatric diagnosis and secondary substance abuse issue


Hahnemann University Hospital

• Established in 1885 • Located in the heart of Philadelphia • 541 licensed beds • Tertiary care academic medical center• Ranked one of nation’s top 50 hospitals for heart care (U.

S. News & World Report, 2007)• Region’s first and only artificial heart implant (5th in the

world)• Region’s first and only designated-training site for the

recently FDA-approved carotid stent system


Hahnemann University Hospital

• Site of one of the region’s first kidney transplant, in 1963• Site of region’s first bone marrow transplant, in 1976• Region’s first designated Level 1 trauma center• Region’s first regional air medical program (MedEvac)• Region’s first partnership with The Wellness Community

for on-site Cancer support groups• Region’s first robotic bariatric and gynecologic surgeries• More than 35,000 Emergency Department visits annually


St. Christopher's Hospital for Children

• Located in Philadelphia • 170-bed pediatric hospital

The hospital provides a wide range of pediatric, medical and surgical specialties through its affiliation with Drexel University College of Medicine. With a medical staff of more than 270 pediatric specialists, St. Christopher's is a Level I Pediatric Trauma Center and provides programs such as kidney transplantation, cancer treatment, burn and wound care, minimally invasive surgery, and open heart surgery for children of the greater Philadelphia area and around the world. The hospital is fully accredited by the Joint Commission, the nation’s oldest and largest hospital accreditation agency.


St. Christopher's Hospital for Children

The hospital is home of the Cystic Fibrosis (CF) Center, which is accredited by the National Cystic Fibrosis Foundation and is part of the Tenet Healthcare System. Through the Center’s affiliations with Drexel University College of Medicine, an Adult CF Program is available at Hahnemann University Hospital in order to better transition individuals living with CF from childhood to adulthood.

In addition, expert training is available for medical students, residents and allied health professionals in the care of CF.


Saint Peter's University Hospital

• Incorporated in 1908• Located in New Brunswick, NJ• 478 bed teaching hospital offering specialized care from

pre-mature babies to geriatrics• 10th hospital in the nation to achieve Magnet status (a

rigorous process that demonstrates the excellence in nursing for the hospital)

• Co-founder of the Cancer Institute of New Jersey (CINJ) and currently a CINJ Clinical Research Affiliate


Saint Peter's University Hospital

Specialty services include:

• Cardiac care for adults offering cardiac catheterization and angioplasty

• Diabetes care and control center for adults and children• Health center for women• A full service Oncology program• Dorothy B. Hersh regional child protection center• Specialized geriatric services, provided through its

Comprehensive Care Group at Monroe, Adult Medical Center at Monroe and Margaret McLaughlin McCarrick Care Center in Somerset

Clinical Research Investigator Pipeline Committee/Forum

• Meetings are open to all Investigators or those interested in becoming an Investigator

• Co chairs include:– Dr. Ari Brooks– Dr. Michael Sherman– Donna Walsh

Training & Development

Training Focus at CRG (What is covered):• Good Clinical Practices (GCP) • Clinical Research Group (CRG) Processes • Guidance Documents

Who is trained?• All DUCOM coordinators and nurse managers• All our affiliate coordinators• 4th year medical students (Clinical Research Concepts)• Department of Medicine Residents and fellows


When does training occur?• During monthly DUCOM CRC scheduled meetings• At scheduled make-up training dates• Self-paced and online• Immediate training on new regulatory updates, outside of

established training dates above• As needed


Where is training done?• New College Building, 19th floor• CRG conference room at 1601 Cherry Street, 3 Parkway

Building, Suite 1000• Other available locations announced before training

How is training conducted?• Interactive instructor-led training• On-line, web-based training• Self-paced, CBTs• Group discussions


Monthly DUCOM Clinical Research Coordinator Meeting:

• This is a forum for all DUCOM clinical research coordinators and nurses, where discussions on study processes, challenges and issues are discussed

• The group also discuss clinical research best practices• They strive to harmonize and standardize all procedures,

with the use of written Guidance Documents, initiated by the Clinical Research Group

• This forum meets every second Thursday of the month, from 12-2 pm, in the Boardroom of the 19th floor, NCB building

• Meeting notifications and reminders are sent before each meeting


Training Schedule:

For scheduled dates, please go to the attached link …….

Marcellina, do you want this slide deleted and in its place, the next slide?

NEO schedule for New Staff

CRG Mentorship for New Staff

• All new staff will attend a 2-day, CRG-managed, on boarding that starts immediately after HR orientation and ends with the staff’s department orientation

• The 2-day on boarding will be followed immediately with a 6-week mentorship program, led by CRG nurses and coordinators

• Each nurse/coordinator has been assigned research process guidelines. These guidelines will help provide mentorship for the new staff

What Comes Next?

• After the two-day onboarding by CRG, new or transferred staff is handed over to the respective departments training

• CRG 6-week mentorship with assigned respective CRG mentors continues for the periods of assignment

Clinical Research Group Guidance Documents

Clinical Research Guidance Documents: These are guidelines to standardize the clinical research process used by staff in the daily conduct of clinical trials. These are located at the Information for Researchers and Staff page.

Clinical Research Resources

Guides for Grant Applications: The NIH Resources webpage can further explain the topics below.

• NIH Office of Extramural Research • Funding Opportunities and Notices • NIH Forms and Applications • Types of Grant Programs • Research Training Opportunities • Submission Dates and Deadlines • New Investigator Program


Educational Information for Grant Applications: The NIH Resources webpage can further explain the topics below

• Getting Started at NIH • Grants Tutorials • Grant Writing Tip Sheet • Resources for New Investigators • Data Sharing Policy • Model Organism Sharing Policy


How Do I Start a Clinical Research Study?The following needs to be completed to initiate a clinical research study:1.Obtain Institution Approval – DrexelMed must allow you to conduct the study.2.Obtain IRB Approval – You must prepare your study for IRB review and approval. 3.Execute Clinical Research Agreement – You must forward any agreements in connection with your study to the designated DrexelMed administrative office.4.Establish Budget – You must ensure that the sponsor of the study is providing sufficient compensation for your study. Although the study budget is usually incorporated into the clinical research agreement, efforts will be needed to establish the budget.


How Do I Start a Clinical Research Study?Clinical research at DrexelMed is managed by administrative offices from both Drexel and DrexelMed. The above activities are all managed by one or more of the following offices:

The above processes do not occur in a vacuum. The above offices work together to ensure all activities are coordinated. For instance, the CRG works with the ORRC to ensure that contract provisions are consistent with the informed consent that is approved by the IRB.

DrexelMed Drexel

Clinical Research Group (CRG)

Office of Regulatory Research Compliance (ORRC)

Office of the Vice Dean for Research

Office of Research Compliance Administration (ORCA)


How Do I Start a Clinical Research Study?

In fact, much of the activities above are combined in one single process. For instance, the forms and documents submitted to ORRC for IRB review is also used by the Office of the Vice Dean for Research to review and provide Institutional approval.

The activities and processes referred above can occur at the same time. For instance, you may submit for IRB approval while the agreement and budget are being finalized (provided the sponsor permits).


How Do I Start a Clinical Research Study? Where Do I Go?

DrexelMed has separate processes to complete the below activities depending on how a clinical research study is funded. Below is a chart to direct you to the correct office for the below activities:

Industry Funded Government / Private Foundation Funded

IRB Review/Institutional Review ORRC ORRC

Contract CRG ORCA

Budget CRG ORCA


Research Coordinator Responsibilities• The primary responsibility of the research coordinator is to

facilitate the daily activities required of clinical research• Report directly to the Principal Investigator • Ensures required training has been completed by study

personnel• Always maintain site in anticipation of FDA audit• Assist PI with feasibility for new trials based on staff and

resources • Provide mentorship to new research coordinators


Research Coordinator Responsibilities cont.• Performing Research

– Training• Have all study staff complete required study training• Train nursing staff on procedure requirements of the study

– Enrollment• Screening patients

– Inclusion / Exclusion Criteria» PI to provide final confirmation and sign

• Remind PI of enrollment status of the study and enrollment goal• Maintain screen failure log

– Documentation• Collect appropriate data using CRF source doc’s• Maintain subject data according to University and Sponsor policies• Document communication

– Telephone logs– Emails– Meeting minutes

• Report AE/SAE according to sponsor/IRB requirements


Study specific responsibilities of the Research Coordinator

• Collaborate with financial team to develop study budget– Standard of Care vs. Non Standard of Care

• Study Documentation– Set up and maintain regulatory binder– Create required source documentation for the study

• Submission preparation and review– Fabricate consent form and have PI review for accuracy – COI Forms completed by all study personnel– Has required training been completed?


Responsibilities of the Principal Investigator

• A Principal Investigator has absolute responsibility for the overall conduct of a sponsored project, including all technical, programmatic, financial, compliance and administrative aspects. The Principal Investigator is responsible for controlling the technical direction and academic quality of the project, and will ensure that a sponsored project is carried out in compliance with the terms, conditions and policies of the Sponsor and the University

• The principal investigator is responsible for ensuring a research study is conducted according to the investigation plan


Responsibilities of Principle Investigator• Providing protection of rights, safety, and welfare of

human subjects– Primary Investigator should educate subject on purpose, risks,

benefits and procedures of the study– Study subjects should have access to the Primary Investigator

at all times if any study related issues should arise– Concrete understanding of the study protocol and device/drug

that is being studied– Go over safety monitoring reports to have a better sense of

risks of the study– Meet with research coordinators on a regular basis– In the event human subject is injured, Primary Investigator

should ensure that adequate medical care is provided


Principle Investigator Study Specific Responsibilities

• Delegation of study related tasks appropriately• Determine study feasibility at research site• During screening phase, provide final feedback on subject

I/E criteria• AE/SAE’s are reported in timely fashion• Follow protocol, complete required procedures, and avoid

deviations• Would our site be ready for an FDA audit?


Eligibility for Principal Investigator StatusGranted to all regular full time faculty including

• Emeriti, research professors and officers of the University who hold director-level administrative positionsVisiting scholars will not be granted Principal Investigator status under any circumstances

• Student Investigators are not eligible for Principal Investigator status, but may be permitted to conduct sponsored projects under the direction of a faculty advisor

• Postdoctoral fellows, lecturers, adjuncts, instructors and other professional staff may be eligible for Principal Investigator status in certain circumstances as described in the next slide


Process for a Petition to Grant Principal Investigator Status

• Individuals who do not meet University eligibility requirements may be granted Principal Investigator

• The petition for Principal Investigator status must be specifically approved on a case-by-case basis

• A petition to request Principal Investigator status should be submitted to the respective dean, director or vice president for first review and approval– The applicant’s review package must include:

• A letter of endorsement from a senior faculty member• A letter of endorsement from the department head• The approval of the respective dean, director or vice president• The applicant’s curriculum vitae• The applicant’s written request for consideration which must include the research

plan, the proposed sources for external support, a space utilization summary and a statement of how the project will further the University’s mission

• All requests must be approved by the head of the applicant’s academic or business unit and sent to the attention of the Vice Provost for Research, Office of Research Compliance and Administration, 3201 Arch Street, Suite 100


Regulatory Requirements • IRB submission (full review)

– Project Submission Transmittal Form – Full Review/Expedited Review Combined Form– Co-Investigator Form if more than 2 Co-Investigators involved in

study– Conflict of Interest Form

• Primary Investigator, Sub-Investigator, Study staff – Research Proposal or NIH Grant (Thesis/Dissertation Proposal)– Investigator’s Brochure (If Applicable)– Informed Consent

• Review by Primary Investigator – Assent Form

• Pediatric Studies – Copy of Advertisement (If Applicable)– Data Collection Instrument (If Applicable)– Radiation Safety Form (If Applicable)– Bio-safety Form for Risk Groups 3 & 4 (If Applicable)– Human Specimens Study Registration Form (All Risk Groups)


Important addresses and Phone Number(s):Clinical Research Group: phone– (215) 255-7879

fax– (215) 255-7885

Help Desk: phone– (215) 762-1999

Hahnemann Library: phone– (215)762-7631

Center City Bookstore: phone– (215) 762-7629


When to use DUCOM services:

Human Resources:http://www.drexel.edu/admin/hr_hs/

Comptroller`s Officehttp://www.drexel.edu/depts/compt/payroll/basics_med.html


When to use Drexel University services:

Gymhttp://www.drexeldragons.com/sports/2007/2/14/

membership_fees.aspx?tab=membershipinformation

Shuttlehttp://www.drexel.edu/facilities/ShuttleBrochure.pdf


When to use Drexel University services (cont):

Holiday ScheduleMONTH HOLIDAY January New Year’s Day

*possible Day after New Year`s Day

January Martin Luther King DayMay Memorial DayJuly Independence DaySeptember Labor DayOctober Columbus DayNovember Thanksgiving DayNovember Day after ThanksgivingDecember Christmas Day

*possible Day after Christmas Day

Updated schedule with exact dates: http://www.drexel.edu/HR/benefits/du-holidays.html

Clinical Research Group New Employee Orientation

Health & Medicine

Transcript of Clinical Research Group New Employee Orientation