Senior Clinical Research Associate

Adicet Bio, Inc • Fulltime • San Carlos, CA, USA, United States • $114k - $158k / year • 3m ago

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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Senior Clinical Research Associate

A Senior Clinical Research Associate will work closely with clinical operations and the cross-functional study execution team to implement all aspects of clinical trials to support multiple clinical programs. The position will liaise with clinical sites, central labs, biomarker labs and internal stakeholders to ensure successful execution across Adicet’s clinical programs.

Key responsibilities include:

The (Sr.) CRA is primary point of contact for clinical sites and will act as a site monitor who is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs
Conduct study site evaluation visits (PSSV), site initiation visits (SIVs), routine monitoring visits (IMVs), and site close out visits.
Perform various study start-up activities: work with sites to collect appropriate regulatory documents, support/assist with the negotiation of contracts and budgets, perform training for clinical sites to ensure proper data collection and report any potential safety-related events, manage the site’s activities during study maintenance, and closing research activities at the sites once the study has concluded

- Develop collaborative relationships with investigative sites, and study vendors
- Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
- Track study-specific items to ensure all required information regarding site issues, deviations, and CRF status are kept current
- Verify proper management and accountability of Investigational Product
Develop and update multiple study tracking documents: subject tracking, essential document tracking, and sample collection/management
Perform Serious Adverse Event (SAE) reconciliation and work with study sites and cross functional teams to resolve discrepancies
Collect, track and review for completeness site regulatory documents for TMF filing
Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
Other duties as may be assigned
Ability to travel up to 50 - 75%

Qualifications:

BS with 2+ years’ experience in pharmaceutical or biotech industry
Experience working directly with clinical sites
Solid understanding of cGMPs, clinical operations, and drug development processes
Detailed oriented with ability to work in a fast-changing environment
Excellent interpersonal, oral, and written communication skills
Superior organizational skills with attention to details
Ability to work with little or no supervision
Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Pay Range

$114,000—$158,000 USD

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.