Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Clinical Scientist in cell therapy responsible for design and execution of clinical trials. Collaborating with cross-functional teams and external partners to ensure study success.
Responsibilities
- Responsible for design and execution of assigned clinical trial activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Develop Protocol and ICF documents/amendments and present these to governance committee
- Conduct literature review and submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Monitor clinical data for specific trends
- Ensure CRF design aligns with data collection in collaboration with Data Management/Programming
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 5 to 10 years of appropriate alternative experience (new entrance to pharma)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
Benefits
- Wide variety of competitive benefits
- Services and programs that provide resources to pursue goals
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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