Title: Clinical Regulatory Coordinator
Duration: 6 Month
Location: On site- Cambridge, MA
Hours Expected: 40 hours per week
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Day to Day Duties/Responsibilities/ Scope of Work:
- Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities.
- Maintain Trial Master Files.
- Act as a liaison between the Site IRBs and Clinical team to resolve regulatory queries and concerns.
- Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.
- Working knowledge of ICH GCP and FDA guidelines
- Knowledge of and direct experience with Trial Master Files.
- Prior regulatory operations experience desirable.
- Fundamental knowledge of conduct of clinical trials is preferred.
- Strong focus on teamwork, attention to detail, excellent organizational skills.
- Must have ability to prioritize, and the ability to work in a multi-task environment.
- Must be able to work independently.
- Must maintain confidentiality of information
- Demonstrate good decision-making and judgment.
- eTMF (e.g. Veeva) experience preferred.
- Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
- 1-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
Sthree US is acting as an Employment Business in relation to this vacancy.