Clinical Regulatory Coordinator/Specialist

Location: Cambridge, Massachusetts Salary: competitive
Sector: Pharma & Biotech, Public Sector, Quality & Supply Chain, Engineering & Validation, Clinical Research, R&D, Quality Assurance (QA), Operations, Pharmacovigilance, Datenmanagement und Biostatistik Type: Contract

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.