Job Description
Senior Clinical Research Associate
Location : Foster City, CA
Reports to : Associate Director, Clinical Operations
Who We Are: 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.
Who We Are Looking For: 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).
What You'll Do: - Working under the direction of the study lead(s), support global study by completing assigned tasks which include, but are not limited to:
- 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.
Key Qualifications:
- 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%.
Why Join Terns Pharmaceuticals?
At Terns, you'll have the opportunity to make a lasting impact at a company on the forefront of transforming oncology. You'll work alongside a passionate and experienced team driven by science and innovation, and committed to improving the lives of patients. This is a unique opportunity to contribute to the growth and success of a promising biopharma company at a pivotal moment in its journey.
The expected base pay for this full-time exempt position is $135 - $160 + bonus + equity + benefits. At Terns, our salary ranges are determined by role, level, and location. The ranges are subject to change and individual pay within that range can vary for several reasons including location, skills/capabilities, experience, and available budget.
Terns Pharmaceuticals is committed to being an Equal Opportunity Employer and our policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.
Job Tags
Full time, Work experience placement,