Clinical Trial Associate

About the role

The Role: GenerateBiomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support clinical trials within our Clinical Development team. Reporting into Clinical Operations, this role will play a critical part in enabling high-quality execution of pivotal trials designed to support regulatory submissions and eventual product approval.

Responsibilities

• Support execution of Phase 1-3 clinical trials, including global site activation, study conduct, and closeout activities.
• Manage Trial Master File (TMF) setup, maintenance, and QC to ensure real-time, inspection-ready documentation.
• Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators (KPIs).
• Cookordinate with internal teams and vendors to ensure trial activities align with the stringent regulatory requirements of Phase 1-3 trials.
• Assist in the collection and review of essential regulatory documentation required for trial initiation and maintenance.
• Organize study meetings, manage action and decision logs, and ensure high-quality documentation of operational progress.
• Track progress against timelines, escalate risks or delays, and contribute to mitigation planning.
• Support clinical audit readiness efforts, including document review, reconciliation, and regulatory filing preparation.
• Maintain informed consent and protocol amendment tracking across global trial sites.
• Assist in clinical vendor invoice reconciliation and budget tracking.

Requirements

• Bachelor’s degree; life sciences or related degree preferred
• 6 months to 1 year of experience supporting Phase 1-3 clinical trials at a sponsor or CRO
• Proficient in clinical systems (eTMF, CTMS) and knowledgeable of FDA and ICH-GCP requirements for pivotal studies
• Demonstrates strong organizational skills, problem solving, and effective communication
• Demonstrates understanding of the clinical drug development process, including study design, protocol objectives and operational impacts
• Understands site management and monitoring practices, including importance of data quality/integrity, as well as fundamental understanding of protocol deviation identification and reporting
• Must be proficient in MS Office applications (word, excel, and PowerPoint at a minimum)
• To support study/program documentation and deliverables
• Basic understanding and importance of current ICH-GCP regulations/guidelines is required

Qualifications

• Enthusiastic, proactive, collaborative, and dependable
• Able to problem solve
• Comfortable in a fast-paced environment and able to manage and prioritize competing tasks
• A preferred candidate has been identified for this role but all applicants will be considered

Benefits

GenerateBiomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Pay

Per Year Salary Range $79,000—$103,000 USD