Clinical Research Manager
About The Position
The Clinical Research Coordinator IV trains research staff, supervises staff and oversees clinical trials from start-up to close-out. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level. Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (i.e. continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge. Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc. Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc. Oversees documentation efforts to ensure compliance with domestic and international regulations and standards. Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.
Requirements
- Bachelor’s Degree Required
- 5 years of clinical research experience (with Bachelor's Degree)
- 3 year clinical research experience (with Master's Degree)
- 2+ years of lead/Project Management experience
Responsibilities
- Trains research staff
- Supervises staff
- Oversees clinical trials from start-up to close-out
- Develops and/or contributes to standard operating procedures and processes
- Attends and engages in leadership meetings
- Represents TJU internally and externally
- Oversees research operation in department
- Provides expert consulting at an institutional level
- Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking
- Directs the preparation and submission of regulatory agency applications, reports, and correspondence
- Provides direct supervision of the research staff
- Conducts on-going training
- Reviews workloads
- Completes annual evaluations
- Oversees documentation efforts to ensure compliance with domestic and international regulations and standards
- Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs
Benefits
- medical (including prescription)
- supplemental insurance
- dental
- vision
- life and AD&D insurance
- short- and long-term disability
- flexible spending accounts
- retirement plans
- tuition assistance
- voluntary benefits
- tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service
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What This Job Offers
Job Type
Full-time
Career Level
Manager
