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Clinical Regulatory Coordinator
Ref No.: 19-04195
Location: Cambridge, Massachusetts
Job Title: Clinical Regulatory Coordinator
Duration: 6 Months
Location: Cambridge, MA

Job description:

We are looking for a detail-oriented clinical professional to join our growing Clinical team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS).

Responsibilities:
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.

Education:
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

Thanks and Regards, 

Shiva Prasad
Sunrise Systems Inc.
Desk: (732) 272 0346
Email: shiva.p@sunrisesys.com | URL: www.sunrisesys.com