Bicara Therapeutics · 2 days ago
Clinical Trial Associate
Boston
Full-time
Hybrid
Mid Level
$100K/yr - $121K/yr
3+ years expBicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with solid tumors. The Clinical Trial Associate (CTA) will support the planning and management of clinical trials, ensuring compliance with regulatory requirements and facilitating communication among stakeholders.
BiopharmaBiotechnologyLife ScienceOncologyTherapeutics
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
Qualification
Required
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
Preferred
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
Bicara Therapeutics
Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$313MKey Investors
Biocon
2024-09-13IPO
2023-12-12Series C· $165M
2023-03-06Series B· $108M
Leadership Team
Claire Mazumdar
Chief Executive Officer
David Raben
CMO, Bicara Therapeutics
Recent News
2026-01-13
2026-01-12
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