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Clinical Regulatory Coordinator/ Specialist
Ref No.: 18-11128
Location: Cambridge, Massachusetts
Job Title: Clinical Regulatory Coordinator/ Specialist
Duration: 8 months
Location:­ Cambridge, MA

Job Description:

CLIENT is looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) of Clinical Regulatory Specialist (CRS).

  • 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
  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
  • 0-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
Shiva Prasad
Sunrise Systems Inc.
Desk: (732) 272 0346
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