Clinical Trial Associate

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