Senior Clinical Trial Associate – Remote

BioAge Labs; United States; Remote; USD 80,000 - 90,000; Full time

Job summary

BioAge Labs seeks a Clinical Trial Associate (Senior CTA) to join our Clinical Operations team. The role supports Phase 1–3 trials, ensuring TMF quality, inspection readiness, and compliance with ICH/GCP and SOPs, in collaboration with CTMs, CROs, vendors, and investigative sites.

The CTA will maintain accurate data in eTMF/CTMS/EDC, assist with protocol and consent form development, and help coordinate IRB/IEC submissions and regulatory documents.

Qualifications

• Bachelor's degree in a scientific or healthcare field, or equivalent experience.
• 2–3+ years of clinical operations experience in biotech, pharmaceutical, or CRO settings.
• Experience supporting Phase 1–3 clinical trials.
• Hands-on TMF management with eTMF, CTMS, and EDC.
• Working knowledge of ICH/GCP and 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.

Responsibilities

• Independently support and coordinate clinical trial activities from start-up through close-out.
• Partner with CTMs to ensure milestones, timelines, and deliverables.
• Serve as primary owner of TMF quality, completeness, and inspection readiness.
• Perform 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 escalate issues as needed.
• Support IRB/IEC submissions and review regulatory documents for compliance.
• Maintain data in clinical systems (eTMF, CTMS, EDC).
• Assist with development and review of protocols, informed consent forms and study manuals.
• Support preparation and tracking of IRB/IEC submissions and regulatory documentation.
• Coordinate and track laboratory samples from sites to labs, ensuring timely shipment and documentation accuracy.
• Participate in meetings, prepare agendas, minutes, and action items.
• Prepare and manage study communications, including newsletters and study updates.
• Contribute to audit and inspection preparation activities.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Education

Bachelor's degree in scientific/healthcare field

Tools

eTMF

CTMS

EDC

Job description

BioAge Labs seeks a Clinical Trial Associate (Senior CTA) to join our Clinical Operations team. The role supports Phase 1–3 trials, ensuring TMF quality, inspection readiness, and compliance with ICH/GCP and SOPs, in collaboration with CTMs, CROs, vendors, and investigative sites.

The CTA will maintain accurate data in eTMF/CTMS/EDC, assist with protocol and consent form development, and help coordinate IRB/IEC submissions and regulatory documents.