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Apex Systems · 5 days ago

Sr. Clinical Study Associate III

Cambridge, MA

Full-time

Onsite

Mid, Senior Level

$70/hr - $86/hr

3+ years exp

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. They are seeking a Sr. Clinical Study Associate to join their Clinical Operations team, playing a key role in supporting the execution of global clinical trials, including site start-up and patient enrollment.

Human ResourcesInformation TechnologyRecruiting

Responsibilities

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

Qualification

Clinical Operations experienceClinical Practices (GCP)Database management applicationsWord proficiencyExcel proficiencyPowerPoint proficiencyBachelor’s degreeCommunication skills