Senior CTA – Drive Oncology Trials & Study Operations

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 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.