Sr Clinical Study Associate III

Sr. Clinical Study Associate III

Our Cambridge based client is seeking a Sr. Clinical Study Associate to join their Clinical Operations team and play a key role in supporting the execution of global clinical trials. This position will be central to site start‑up, patient enrollment, monitoring, and ensuring smooth data flow across sites, CROs, and central labs. This position requires 3x per week onsite in Cambridge MA.

What You’ll Do

• Support day‑to‑day clinical trial activities in partnership with the Clinical Study Manager and team.
• Prepare study documents including consent forms, site instructions, Manuals of Operations, and Pharmacy binders.
• Track and file essential documents in the Trial Master File (TMF); review site documents for accuracy.
• Monitor patient status across investigative sites and oversee sample collection, lab reporting, and testing schedules.
• Liaise with CROs and vendors to ensure proper sample handling, shipment, and reporting.
• Review monitoring trip reports, track data queries, and evaluate site performance.
• Attend site initiation, monitoring, and close‑out visits at select sites.
• Ensure data quality and assist in resolving subject eligibility and protocol deviation issues.
• Contribute to investigator/vendor meetings and study feasibility assessments.
• Coordinate activities with third‑party vendors, including metrics, accruals, and process planning.

Requirements

• Experience: 3 years in the industry, preferably in Clinical Operations; experience with global clinical trials.
• Knowledge: Strong understanding of Good Clinical Practices (GCP), SOPs, and study phases in clinical development.
• Technical Skills: Advanced proficiency in Word, Excel, PowerPoint; familiarity with database management applications.
• Communication: Excellent verbal and written communication skills.
• Education: Bachelor’s degree or higher required.