Lead Clinical Research Associate

Position Overview:

As a Lead Clinical Research Associate (CRA) at Bicara Therapeutics, you will support the planning and execution  of clinical trials to ensure they meet regulatory standards and timelines. This role will primarily focus on monitoring clinical trial data, site management, ensuring compliance with Good Clinical Practice (GCP), and assisting in various aspects of clinical trial management. You will work closely with study teams, clinical sites, and vendors to support trial execution and provide critical operational support.

Key Responsibilities:

• Assist in the preparation, initiation, and execution of clinical trials, ensuring adherence to timelines and regulatory requirements.
• Assist with site selection and initiation including attendance at remote or onsite site evaluation visits (SEVs) and site initiation visits (SIVs), ensuring site and staff qualification and readiness to conduct clinical trial.
• Attendance at remote or onsite interim monitoring visits (IMVs) and/or close out visits (COVs) ensuring the proper implementation of clinical trial protocols, study plans and regulatory requirements.
• Review and maintain clinical trial documentation, ensuring it is complete, accurate, and compliant with all regulatory requirements.
• Support the preparation of regulatory submissions.
• Ensure that all trial activities are conducted according to the study protocol, GCP, and applicable regulations.
• Track and report clinical trial metrics and site performance, helping to ensure that studies stay on schedule and within scope.
• Review and monitor study reports and assist in resolving any issues regarding adverse events or protocol deviations.
• Maintain accurate, up-to-date files for all clinical trial documentation, ensuring compliance with internal standard operating procedures (SOPs) and regulatory guidelines.
• Support Sponsor oversight activities including risk management, eTMF reviews, and oversight visits, reporting, and follow-up.
• Liaise with CRO partner and other internal and external stakeholders in day-to-day operations of outsourced clinical trial activities
• Ability and willingness to travel as needed (up to 50%, with potential for increase during start-up, data locks and close-out)

Qualifications:

• Bachelor’s degree in Life Sciences or a related field
• Minimum of 2 years of experience as a Clinical Research Associate or in clinical trial management, with a focus on site management and trial monitoring of Phase I, II, and II studies; oncology experience with both Sponsor and CRO preferred.
• Current ICH GCP training (within the last 3 years)
• Experience with Medidata Rave and CTMS
• Excellent organizational and time-management skills with the ability to manage multiple tasks and priorities.
• Strong attention to detail and accuracy in data management and documentation.

Company Overview
Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. 

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.