Clinical Trial Associate

Position Overview

The Clinical Trial Associate (CTA) at Bicara Therapeutics plays a critical role on the Clinical Operations team by supporting the planning, execution, and management of clinical trials. The CTA will work closely with Clinical Trial Managers (CTMs) and other cross-functional teams to ensure that trials are conducted efficiently, in compliance with regulatory requirements, and in accordance with the study protocol. This position will report to our Director, Clinical Operations.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities in close collaboration with Clinical Trial Managers and CRO.
• Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
• Facilitate effective communication between study sites, clinical trial managers, and other stakeholders by managing correspondence, scheduling meetings, and distributing study-related information.
• Support the site start-up process including document collection, tracking and communication with CRO teams. Monitor site performance metrics and follow up on any outstanding issues.
• Assist in the preparation, submission, and tracking of regulatory documents to ensure compliance with local and international regulations (e.g., FDA, EMA, ICH-GCP).
• Collaborate with data management teams to track case report form (CRF) completion and query resolution. Ensure data is accurately captured and reported.
• Coordinate with external vendors (e.g., CROs, labs, etc.) to ensure timely delivery of services and supplies required for trial conduct.
• Assist in tracking trial budgets, manage study trackers and reports to ensure visibility into timelines and deliverables.
• Participate in monitoring activities and internal audits to ensure adherence to study protocols and regulatory requirements. Report findings and assist in implementing corrective actions as needed.

Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field.
• 3 years of experience in clinical research or related fields, with 1 year of experience within the biopharmaceutical industry.
• Experience in oncology
• Strong understanding of ICH-GCP, clinical trial regulations, and start-up processes.
• Excellent organizational and time management skills with the ability to handle multiple priorities.
• Strong communication skills, both written and verbal, with the ability to work collaboratively in a small, fast-paced biotech environment.
• Proficiency in Microsoft Office Suite including strong skills in Excel
• Attention to detail and a commitment to maintaining high-quality standards.
• Ability to work independently and solve problems proactively.
• Previous experience working with contract research organizations (CROs) and external vendors, preferred
• Knowledge of clinical trial management systems (CTMS), electronic trial master file (eTMF) and electronic data capture (EDC) system, preferred
• Working knowledge of data management, query resolution, and supply chain logistics, preferred

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.