Clinical Trial Associate/Senior Clinical Trial Associate

Crescent Biopharma; Waltham (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Crescent Biopharma in Waltham, MA, seeks a CTA/Senior CTA to support clinical trials under the Clinical Study Lead. You will help ensure studies run on time, within budget, and in compliance with FDA regulations and ICH/GCP guidelines.

You may independently manage components of studies, oversee CROs and sites, maintain trial documentation, and collaborate across Regulatory, Data Management, Safety, and Quality teams to drive study deliverables.

Qualifications

• Bachelor’s degree in scientific or related field; 2+ years in Clinical Operations or clinical research.
• Knowledge of FDA regulations and ICH/GCP guidelines.
• Demonstrated efficiency in coordinating multiple study activities.

Responsibilities

• Support Clinical Study Lead and Operations team to meet study objectives and timelines.
• Oversee CROs, vendors, and investigator sites; review monitoring reports and actions.
• Maintain study tracking tools (e.g., Form FDA 1572) and site activation milestones.
• Support Trial Master File (eTMF) activities: collection, filing, reconciliation, and inspections readiness.
• Prepare study agendas, meeting minutes, action logs, and status reports with cross-functional teams.
• Collaborate with Regulatory Affairs, Clinical Supplies, Data Management, Safety, and Quality.

Skills

Vendor oversight

Regulatory knowledge

Communication

Cross-functional collaboration

Education

Bachelor’s degree in scientific or related field

Job description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapiesas single agentsand as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a CTA/Senior CTA who will work with the Clinical Study Lead and Director of Clinical Operations to support the conduct of clinical trials. You will partner with the Clinical Study Lead to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

You may independently manage components of clinical studies, including but not limited to vendor oversight, budgets, responsibility for a subset of sites or countries, or phases of the trial (startup period, for example), with oversight.

Responsibilities

• Support the Clinical Study Lead and Clinical Operations team in the day-to-day operational activities of clinical trials to ensure study objectives, timelines, quality standards, and regulatory requirements are met.
• Support oversight of CROs, vendors, and investigator sites, including review of monitoring visit reports, site communications, and follow-up on study-related actions and issues.
• Maintain study tracking tools for key study documentation (e.g., Form FDA 1572) and operational activities, including site activation, enrollment, monitoring visit status, IRB/EC approvals, safety letter distribution, training compliance, and study milestones.
• Support Trial Master File (eTMF) activities, including document collection, filing, reconciliation, quality control reviews, and inspection readiness efforts.
• Support preparation of study agendas, meeting minutes, action item logs, and study status reports while ensuring effective communication across internal teams, CROs, vendors, and investigator sites.
• Collaborate cross-functionally with Regulatory Affairs, Clinical Supplies, Data Management, Safety, Quality, and other functional areas to support study deliverables and timelines.
• Manage study team training records and ensure compliance with applicable SOPs, regulations, study requirements, and company policies.
• Manage system access requests for study team and site personnel, as needed.
• Communicate and elevate study risks, protocol deviations, operational challenges, and other study-related issues as appropriate.

Education & Experience

• Bachelor’s degree in scientific or related field with 2+ years of experience in Clinical Operations, clinical research or healthcare, or equivalent experience
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
• Demonstrated efficiency