What are the responsibilities and job description for the Clinical Trial Associate position at Bicara Therapeutics?
About Bicara Therapeutics:
Bicara Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. Our mission is to bring groundbreaking treatments to patients with serious conditions by leveraging cutting-edge science and fostering a collaborative, dynamic work environment.
Job Summary:
The Clinical Trial Associate (CTA) at Bicara Therapeutics plays a critical role in the clinical operations team, supporting the planning, execution, and management of clinical trials. The CTA will work closely with Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), and other cross-functional teams to ensure that trials are conducted efficiently, in compliance with regulatory requirements, and in accordance with the study protocol.
Key Responsibilities:
- Trial Support: Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
- Documentation Management: Maintain, organize, and update trial master files (TMF) and essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
- Communication: Facilitate effective communication between study sites, clinical trial managers, and other stakeholders by managing correspondence, scheduling meetings, and distributing study-related information.
- Site Coordination: Support the site selection process and assist in the preparation of essential documents for site initiation. Monitor site performance metrics and follow up on any outstanding issues.
- Regulatory Compliance: Assist in the preparation, submission, and tracking of regulatory documents to ensure compliance with local and international regulations (e.g., FDA, EMA, ICH-GCP).
- Data Management: Collaborate with data management teams to track case report form (CRF) completion and query resolution. Ensure data is accurately captured and reported.
- Vendor Management: Coordinate with external vendors (e.g., CROs, labs, etc.) to ensure timely delivery of services and supplies required for trial conduct.
- Budget Tracking: Assist in tracking trial budgets, processing invoices, and maintaining financial records related to clinical trial expenses.
- Quality Control: 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.
- 1-3 years of experience in clinical research or related fields, preferably within the biopharmaceutical industry.
- Strong understanding of clinical trial processes and regulations (e.g., ICH-GCP, FDA, EMA).
- 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 effectively in a team environment.
- Proficiency in Microsoft Office Suite including strong skills in Excel and Smart Sheet
- Familiarity with electronic data capture (EDC) systems.
- Attention to detail and a commitment to maintaining high-quality standards.
- Ability to work independently and solve problems proactively.
Preferred Qualifications:
- Experience with trial master file (TMF) management and clinical trial documentation.
- Previous experience working with contract research organizations (CROs) and external vendors.
- Knowledge of clinical trial management systems (CTMS) and electronic trial master file (eTMF) systems.
- Working knowledge of data management, query resolution, and supply chain logistics
Why Bicara Therapeutics?
At Bicara Therapeutics, you’ll be part of a passionate team dedicated to advancing medical science and improving patient outcomes. We offer a collaborative and innovative environment where you can grow your career while making a meaningful impact on global health.