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Clinical Regulatory Coordinator/ Specialist
Ref No.: 18-11617
Location: Cambridge, Massachusetts
We are looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) of Clinical Regulatory Specialist (CRS).
Responsibilities:
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.
Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and 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

Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
Knowledge of and direct experience with Trial Master File and prior regulatory experience desirable.
Fundamental knowledge of the 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
Experience Electronic Data Capture (EDC) such as Inform for clinical trials
Detail-oriented and comfortable with tight timelines
Experience with controlled clinical terminology is helpful but not required
Knowledge of and direct experience with Trial Master File and eTMF (ie.Veeva) experience and Microsoft office desirable