Clinical Trial Associate (or Senior)BioAge is seeking a
Clinical Trial Associate (Senior CTA) to join our Clinical Operations team.
Position SummaryThe CTA plays a critical role in the execution of Phase 1-3 clinical trials and is responsible for ensuring operational excellence, inspection readiness, and compliance with ICH/GCP guidelines and company SOPs. This position partners closely with Clinical Trial Managers, CROs, vendors, and investigative sites to support timely and high-quality study delivery.
Key Responsibilities- Independently support and coordinate clinical trial activities from start-up through close-out.
- Partner with CTMs to ensure operational milestones, timelines, and deliverables are achieved.
- Serve as primary owner of Trial Master File (TMF) quality, completeness, and inspection readiness.
- Perform ongoing TMF quality control and resolve documentation gaps with internal teams and vendors.
- Collaborate with CROs, vendors, and sites to ensure study milestones and deliverables are met.
- Track study timelines, identify risks, and proactively escalate issues as needed.
- Support IRB/IEC submissions and review essential regulatory documents for compliance.
- Maintain accurate and timely data within clinical systems (eTMF, CTMS, EDC).
- Assist with development and review of key clinical documents, including protocols, informed consent forms and study plans/manuals.
- Support preparation, review, and tracking of IRB/IEC submissions and regulatory documentation.
- Coordinate and track laboratory samples from investigative sites to central and specialty laboratories, ensuring timely shipment, reconciliation, and documentation accuracy.
- Participate in internal and external meetings, including preparation of agendas, meeting minutes, and action item tracking.
- Prepare and manage study communications, including newsletters and study updates as needed.
- Contribute to audit and inspection preparation activities.
Qualifications and Required Skills- Bachelor's degree in a scientific or healthcare-related field preferred; equivalent experience considered.
- 2-3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings.
- Experience supporting Phase 1-3 clinical trials.
- Hands-on experience with TMF management and clinical systems (eTMF, CTMS, EDC).
- Working knowledge of ICH/GCP and applicable regulatory requirements.
- Strong organizational skills and exceptional attention to detail.
- Ability to manage multiple priorities in a fast-paced, collaborative environment.
- Excellent written and verbal communication skills.
Preferred Qualifications- Experience in a small or early-stage biotech company.
- Experience supporting audit or regulatory inspection readiness.
- Experience working with global or multi-site clinical trials.
- Prior CRO oversight experience.
Our workplaceBioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. Many positions (including this one) are remote, allowing our team members to work from anywhere. The salary for this role is expected to be approximately $80,000 - 90,000, depending on experience. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.
