Senior Clinical Study Associate Job at Proclinical (Cambridge)

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

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Senior Clinical Study Associate

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