Senior Clinical Research Associate

Terns Pharmaceuticals•Foster City, CA

5d•$135 - $160

About The Position

Terns Pharmaceuticals is a global biopharmaceutical company committed to developing transformative therapies for patients with serious diseases. With a pipeline of innovative oncology programs, including TERN-701, a next-generation allosteric BCR-ABL inhibitor now advancing into pivotal clinical trials for chronic myeloid leukemia (CML), we are dedicated to building a future where precision medicines improve patient lives and outcomes. We are seeking a highly motivated individual to join the Clinical Operations group. This position reports into the Associate Director, Clinical Operations, and is responsible for supporting the study team with study execution and providing logistical support in managing the full scope of clinical trial(s), coordinating cross-functional team and vendor efforts, and ensuring the clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, regulations, and ICH/GCP guidelines in accordance with the Clinical Development Plan (CDP).

Requirements

BA and/or MS in Life Science or related discipline plus 7+ yrs or equivalent combination of education and work experience
Effective team player and exceptional written and interpersonal communication skills.
Resourceful and able to solve problems independently.
Ability to manage delegated aspects of assigned clinical trials.
Working knowledge of FDA & ICH/GCP regulations and guidelines.
Experience with Medidata RAVE/RTSM, Veeva Vault Quality and TMF system, MS Office Suite, and other applications
Ability to travel up to 15%.

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.