RA Capital

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 the APAC Clinical Trial Manager, Clinical Operations.

This position is remote, with a strong preference for candidates located within the APAC region.

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.

• Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance across assigned regions and sites.

• Proactively identify and escalate operational risks, delays, or quality issues to the Clinical Trial Manager.

• Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.

• Facilitate effective communication among study sites, Clinical Trial Managers, and other stakeholders by managing correspondence, coordinating meetings, and distributing study-related information, including preparing agendas, tracking action items, documenting decisions, and following up on outstanding deliverables.

• Support the site start-up and activation process, including collection and tracking of essential documents in accordance with the EDP; coordination of EC/RA submissions and approvals; vendor coordination; and follow-up with CRO teams to support planned activation timelines. 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, ensuring accurate and timely data capture and reporting. Support the review and follow-up of data query resolution, data cleaning activities, and site responsiveness in collaboration with CRO and Data Management teams.

• 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.

• Support inspection readiness activities through ongoing review of TMF quality, completeness, and document reconciliation activities.

• 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 and prior support of regional or global clinical trials across multiple countries is preferred

• 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

• Ability to operate effectively in a fast-paced, global biotech environment with evolving priorities and timelines

• 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 biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

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.