Sr Clinical Study Associate III

Account Executive at Stratacuity:
Proven Scientific Placement

Sr. Clinical Study Associate III

This position requires 3x per week onsite in Cambridge MA.

Cambridge, MA

$78.00/hr - $86.00/hr

Mid‑Senior level

Contract

Management

Biotechnology Research and Pharmaceutical Manufacturing

• 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.

• 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.

• 401(k)
• Medical insurance
• Vision insurance