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Senior Clinical Study Associate

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Proclinical

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Location:
United States , Cambridge

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Be the backbone of clinical research-join a team shaping tomorrow's therapies. Proclinical is seeking a Senior Clinical Study Associate for a hybrid role based in Cambridge, MA. This is an excellent opportunity to contribute to complex clinical trial activities and collaborate with cross-functional teams.

Job Responsibility:

  • Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring
  • Support the Clinical Study Manager and team members in managing trial activities
  • Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder)
  • Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF)
  • Monitor patient status at investigative sites and ensure accurate tracking
  • Manage sample collection, laboratory testing schedules, and central laboratory reporting
  • Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting
  • Review monitoring trip reports, track data query reports, and assess site visit metrics and performance
  • Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs
  • Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues
  • Contribute to investigator and vendor meetings, including preparation and presentations
  • Support study feasibility assessments and review site contracts and budgets for start-up
  • Coordinate third-party vendor activities, including metrics, accruals, and process planning

Requirements:

  • Strong understanding of clinical trial processes and regulatory requirements
  • Experience with TMF management and document tracking
  • Proficiency in managing laboratory vendors and coordinating sample logistics
  • Ability to review and analyze site performance metrics and monitoring reports
  • Excellent organizational and communication skills
  • Familiarity with site contracts, budgets, and feasibility assessments
  • Ability to work collaboratively with cross-functional teams and external vendors

Additional Information:

Job Posted:
January 05, 2026

Work Type:
Hybrid work
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