The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of clinical trials under the direction of the Vice President, Development Operations, with day-to-day guidance from the assigned Study Lead. The CTA plays a key role in study start-up, ongoing trial execution, and close-out activities, with a primary focus on document management, trial tracking, and operational support.
This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance with applicable regulatory requirements (GCP/ICH), internal SOPs, and company standards.
All activities are conducted in accordance with company policies, SOPs, and corporate values.
POSITION RESPONSIBILITIES
Clinical Trial Support
- Support study start-up activities, including site feasibility, investigator onboarding, and collection of regulatory and essential documents
- Assist with site management activities throughout the trial lifecycle, from start-up through close-out
- Communicate with clinical sites and vendors, as appropriate, to support timely collection of required documentation
- Support investigational product tracking activities, including inventory documentation, shipment tracking, and reconciliation
Trial Documentation & Systems
- Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)
- Support ongoing maintenance of the Clinical Trial Management System (CTMS), ensuring data accuracy and timeliness
- Review, file, and track clinical trial documentation in accordance with SOPs and regulatory requirements
- Assist with quality control (QC) checks of study, country, and site-level documentation and support issue resolution
Study Tracking & Reporting
- Maintain study trackers (e.g., regulatory submissions, site start-up timelines, protocol issue logs)
- Track study progress and generate routine status reports and metrics as requested
- Assist with review of monitoring visit reports (initiation, routine monitoring, and close-out)
Meetings & Cross-Functional Collaboration
- Coordinate and support internal and external study meetings, including preparation of agendas, meeting minutes, and action item tracking
- Collaborate with cross-functional teams, CROs, and vendors to support routine study operations
- Provide general administrative and operational support to Development Operations team as needed
Compliance & Inspections
- Support preparation for and follow-up on audits and regulatory inspections, as applicable
- Assist with review of informed consent documents, case report forms, and other study-related materials
EDUCATION AND EXPERIENCE
- Bachelor's degree (BS/BA) or equivalent preferred
- Minimum of 1-3 years of experience supporting clinical trials, preferably in a pharmaceutical, biotechnology, or CRO environment
TECHNICAL SKILLS & CORE COMPETENCIES
- Foundational knowledge of FDA and/or EMA regulations, ICH guidelines, and GCP requirements
- Basic understanding of clinical trial documentation, filing structures, and operational workflows
- Working knowledge of clinical systems such as eTMF, CTMS, and EDC platforms
- Ability to manage multiple tasks and priorities in a fast-paced clinical development environment
- Strong attention to detail and organizational skills
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
- Effective written, verbal, and interpersonal communication skills
- Ability to work collaboratively across functions with appropriate supervision and guidance
Proposed Compensation Range: 80,000 - 90,000