Clinical Regulatory CoordinatorApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
- Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities
- 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
- 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
- Must have Trial Mast File experience and Veeva Vault experience preferred
- Working knowledge of ICH GCP and FDA guidelines
- Must maintain confidentiality of information, demonstrate good decision-making and judgment
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