Ksr Clinical Introduction 2009 1
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Transcript of Ksr Clinical Introduction 2009 1
October 1, 2009October 1, 2009
An Introduction to Clinical ResearchAn Introduction to Clinical Research
What is Clinical Research?What is Clinical Research?
Clinical research is the scientific evaluation of the safety
and effectiveness of a new investigational medical
treatment, medication or device in human volunteers.
Clinical Research Center of ExcellenceClinical Research Center of Excellence
Team of Consultants dedicated to sourcing, recruiting and
placing clinical research, regulatory and medical affairs, data
management and biostatistics professionals with
pharmaceutical, biotechnology, and medical device companies,
as well as with research facilities, contract research and site
management organizations across the Americas.
The R&D ProcessThe R&D Process
The Clinical Research IndustryThe Clinical Research Industry
Sponsor
CRO
ElectronicApplication Provider
Drug PackagingIVRSCentral LabSMO
Investigator
Study Participant
Clinical Research StepsClinical Research Steps
Study Design
StudyInitiation
Study Enrollment
Study Conduction
StudyCloseout
Drug Accountability
Study Monitoring
Adverse Events Reporting
Data Collection
Clinical Trials – US Study SitesClinical Trials – US Study Sites
12008 Total Studies image - www.clinicaltrials.gov 8/09
KSR Clinical Research – since 1996KSR Clinical Research – since 1996
Recruiting Clinical Research professionals since 1996• Center of Excellence (CoE) Re-launched August , 2008
Experienced management, seasoned recruiters• Collectively, over 100 years recruiting, clinical research and HR consulting experience
Workforce Augmentation (Temporary and Temporary-to-Hire), Executive Search, Project Management
Support Phase I to post marketing
Recruiters are position-focused (e.g. Regulatory Affairs, Clinical Affairs/Operations, Data Management)
Teams aligned geographically
Team approach• Recruiter collaboration on flexible workforce
• Select and submit most qualified candidates
• Share candidate, salary and market intelligence to focus continuing sourcing efforts
• Partner with Kelly’s network of local operations
Proactive sourcing (i.e. recruiters source and network daily) via referral, networking, social media, niche partners, direct marketing and traditional methods
Active membership in Clinical Research & Professional Organizations including: DIA, ACRP, SoCRA, AMWA, AmStat and HBA
Customer Care team dedicated to service, follow-up and support
Clinical Research CompetenciesClinical Research Competencies
Early phase to post marketing support
Industry Experience
• Pharmaceutical
• Medical and Diagnostic Device
• Biotechnology
• Contract (Clinical) Research Organizations
• Site Management Organizations
• Academic Research Institutions
CoE Recruiting CompetenciesCoE Recruiting Competencies
Clinical Operations / Clinical Affairs
• Clinical Research Associates (In-house and Regional)
• Study, Site and Trial Managers
• Project and Program Managers
• Medical Directors
Data Management, Statistical Programming and Biostatistics
• Global Librarians
• Clinical Data Management Associates and Clinical Data Managers
• Statistical Programmers (SAS, Oracle Clinical)
• Biostatisticians, Managers and Directors of Biostatistics
Medical and Regulatory Affairs
• Regulatory Affairs Associates and Managers
• Drug and Product Safety Specialists
• Pharmacovigilance and Safety Surveillance Specialists, Managers
• GCP Auditors
• Medical and Submissions Writers
Additional: Clinical Supplies Managers, Contracts Managers, Business Development Managers
Clinical Research ExpertiseClinical Research Expertise
Therapeutic area experience
• Oncology, Cardiovascular, Diabetes/Endocrinology,
Allergy/Rhinitis, Asthma/Pulmonary, CNS, Infectious
Diseases, Vaccines, Immunology, Acute Care, etc.
Device experience
• Cardiovascular (Rhythm Management, Atrial
Fibrillation, Stent), Orthopedic implant,
Neuromodulation, Imaging, Respiratory, Diabetes
Diagnostic, Oncology Diagnostic, Ophthalmology, etc.