Clinical Research Manager
1 week ago
Nationally ranked, Thomas Jefferson University & Jefferson Health is reimagining health care and higher education to create unparalleled value. With a strong commitment to providing the highest-quality, compassionate clinical care for patients, making our communities healthier and stronger, and preparing tomorrow's professional leaders for 21st-century careers, we are dedicated to creating new knowledge through basic/programmatic, clinical and applied research.
Job SummaryWe are seeking a highly skilled Clinical Research Manager to join our team. The successful candidate will be responsible for training research staff, supervising staff, and overseeing clinical trials from start-up to close-out. This role will also involve developing and/or contributing to standard operating procedures and processes, attending and engaging in leadership meetings, representing the organization internally and externally, and overseeing research operations in the department.
Key Responsibilities- Interact with co-workers, visitors, and other staff consistent with the values of Thomas Jefferson University & Jefferson Health.
- Manage 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.
- Direct 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.
- Provide direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Identify issues, recommend changes, write new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.
- Bachelor's Degree Required
- AND
- Experience:
- Bachelor's Degree and 5 years of clinical research experience or Master's Degree and 3 year clinical research experience.
- 2+ years of lead/Project Management experience.
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