Clinical Research Quality Specialist B
Clinical Research Quality Specialist B
Job Description Summary
Supports clinical research and compliance by partnering with senior team members to conduct reviews, including preparation, implementation, closeout and reporting to ensure adherence to federal regulations and institutional policies. Interfaces with investigators, project managers, sponsors and staff during the review process. Will also lead in the development of consent forms, case report forms, checklists and other study documentation. Will mentor junior staff on good clinical practices in research.
Job Responsibilities
- Assist in the facilitation and conduct of compliance reviews for sponsor and investigators, including preparation, reporting and close-out
- Provide support to investigators and research staff in the development of protocols, informed consent forms, case report forms and other related study documentation
- Conduct training of investigators, sponsors and clinical research staff in areas related to clinical research
- Assist with regulatory submissions and maintenance of documentation
- Partnering with data analytics to develop reports
- Performs additional duties as assigned.
CONTINGENT UPON FUNDING
Requirements: Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required
Job Location: Philadelphia, Pennsylvania
Department / School: Perelman School of Medicine
Pay Range: $62,000.00 - $72,500.00 Annual Rate
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