Position: Clinical Regulatory Coordinator/specialist
Duration: 7 months
Location: Cambridge, MA
Responsibilities of Clinical Regulatory Coordinator/specialist:
- Work closely with Clinical Operations and Regulatory Affairs to ensure compliance
- Liaise 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.
- Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance
- Troubleshoots processes and procedures when issues are identified.
- Review documentation/submissions from departments outside of Regulatory Affairs
- Develop training modules consistent with organizational needs in accordance with current international GCP requirements
- Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings
- Create, review and revise all functional group SOP's
- Maintain Trial Master Files
Requirements for Clinical Regulatory Coordinator/specialist applicants:
- Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy of other related field
- 1-3+ years of clinical research experience
- Willingness to work onsite in Cambridge, MA
As a temporary W2 employee of Real Staffing, you have the option of enrolling into the following offered benefits: medical, dental, vision, 401K, voluntary short/term long term disability and voluntary life insurance
Sthree US is acting as an Employment Business in relation to this vacancy.