Job Title

Position: Clinical Study Associate I Job Description: Key Responsibilities Assist in the planning and execution of clinical trials in compliance with protocol requirements and regulatory standards. Support interactions with Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other study vendors. Support the transmittal of trial- and site-level documents to the Document Control Center (DCC) for Trial Master File (TMF) maintenance. Reconcile TMF document trackers generated by CROs with archived documentation; escalate discrepancies to the supervisor. Coordinate with Regulatory Operations to ensure timely posting of trial information to required public registries (e.g., ClinicalTrials.gov). Track and maintain study metrics, including: Site start-up timelines Investigator/site performance Regulatory documentation status TMF filing and quality control activities Analyze site metrics reports under supervision and escalate potential concerns. Qualifications & Skills: Minimum of 1 year of relevant experience required. Clinical or basic research within a Pharmaceutical, Medical Device, Diagnostic company Contract Research Organization (CRO) Academic Research Organization (ARO) Direct experience in a clinical setting (e.g., Study Site Coordinator) Experience with Veeva systems is a plus. Oncology experience is a plus.