Clinical Research Assistant II at Women & Infants Hospital collecting and processing research data. Following protocols for study activities and recruiting research subjects.
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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