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Terns Pharmaceuticals · 23 hours ago

Senior Clinical Research Associate

Foster City, CA

Full-time

Hybrid

Mid, Senior Level

$135K/yr - $160K/yr

7+ years exp

Terns Pharmaceuticals is a global biopharmaceutical company committed to developing transformative therapies for patients with serious diseases. They are seeking a highly motivated individual to join the Clinical Operations group, responsible for supporting study execution and managing the full scope of clinical trials in compliance with regulations and guidelines.

BiotechnologyHealth CareMedicalMedical DevicePharmaceutical

Responsibilities

Assist in site selection activities, including assessment of potential sites, review of site recruitment questionnaires and pre-site selection visits/calls

Assist with the management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and adherence to scope of work and service agreement

Participate in cross-functional meetings by scheduling sessions, preparing agendas, distributing minutes, and tracking actions and decisions

Contribute to developing, finalizing, and distributing cross-functional deliverables such as case report forms, consent forms, study management plans, study reference manuals, and other clinical documents

Assist with ensuring that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, and reconciled

Assist with training team members, site monitors, and vendors on study protocol and processes

Review monitoring reports and escalate issues and risks to Study or Site Management Lead

Coordinate and participate in review of site and study protocol deviations

Coordinate and participate in routine and final data listings review

Contribute to GCP inspection-readiness activities by working with CRO and cross functional team to lead quality review of the trial master file (TMF) and conduct site audits

Assist with planning investigator meetings and developing content and/or site training materials

Contribute to review of vendor proposals and participate in award recommendations, selection of CROs and vendors under the direction of the Study Lead

Other projects when assigned

Qualification

FDA regulationsICH/GCP guidelinesMedidata RAVEVeeva Vault QualityClinical trial managementLife Science degreeMS Office SuiteInterpersonal communicationProblem-solvingTeam player