Clinical Trial Associate

About the role

The Clinical Trial Associate (CTA) supports the Director of Clinical Operations and Clinical Study Managers in trial start-up, execution, and close-out activities while maintaining high-quality standards and strict compliance with SOPs, policies, and regulatory requirements. This role plays a key part in the successful delivery of clinical studies by providing administrative, operational, and documentation support across the clinical development lifecycle, with a strong focus on rare disease programs.

Responsibilities

• Execute delegated responsibilities across trial start-up, conduct, and close-out in alignment with expected quality standards and timelines.
• Provide comprehensive administrative support to the Clinical Operations Department and Clinical Study Managers, including coordination of study activities and logistics.
• Generate, distribute, and maintain study-related agendas and meeting minutes to ensure clear documentation and follow-up of action items.
• Maintain and update study tracking tools and logs to ensure accurate and current information on trial status and key metrics.
• Cover correspondence with Institutional Review Boards (IRBs) as needed to support submissions, approvals, and ongoing reporting.
• Assist Clinical Study Managers with oversight of CROs and vendors by supporting tracking, communication, and documentation of performance and deliverables.
• Support review and quality control of study-specific documentation, including clinical protocols, informed consent forms (ICF), study plans, study reference manuals, and case report forms (CRFs).
• Collaborate with Document Management to implement and maintain Trial Master File (TMF) specifications in alignment with program milestones and regulatory expectations.
• Perform quality reviews of TMF and eTMF content to ensure compliance with SOPs, ICH-GCP, Good Documentation Practices (GDP), and regulatory requirements.
• Contribute to activities supporting Biologics License Application (BLA) submissions through accurate documentation management and data support.
• Support site management activities, including tracking site documentation, communication, and status updates.
• Aid in data review activities to ensure data quality, consistency, and alignment with study protocols.
• Collaborate with cross-functional stakeholders in a fast-paced environment and proactively identify and resolve documentation or process issues.
• Demonstrate a continuous learning mindset and contribute to process improvements within Clinical Operations and Document Management.

Requirements

• Minimum of 3 years of experience as a Sponsor Clinical Trial Associate (CTA), preferably with a small sponsor environment.
• Minimum of 3 years of experience in pharmaceutical drug development and clinical operations.
• Sponsor-side clinical operations experience, with a focus on supporting clinical trials from start-up through close-out.
• Hands-on experience with Trial Master File (TMF) and electronic TMF (eTMF) systems, including implementation and maintenance of TMF specifications.
• Proficiency with Veeva or similar eTMF/clinical documentation platforms.
• Strong administrative skills and experience supporting clinical documentation and study logistics.
• Working knowledge of the drug development process and clinical trial lifecycle.
• In-depth knowledge of International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines.
• Strong understanding of Good Documentation Practices (GDP).
• Knowledge of and adherence to SOPs and compliance with FDA Code of Federal Regulations.
• Experience supporting inspection readiness activities for clinical trials.
• Experience supporting BLA submission-related documentation and activities.
• Experience with site management activities within clinical studies.
• Experience with data review in a clinical trial setting.
• Proficiency with Microsoft Office applications (such as Word, Excel, PowerPoint, and Outlook) for documentation, tracking, and communication.
• Ability to operate effectively in a fast-paced working environment.
• Strong attention to detail and quality focus in documentation and tracking.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills to support internal and external correspondence.

Qualifications

• Bachelor’s degree (minimum) in a relevant field such as life sciences, healthcare, or a related discipline.
• Experience working on rare disease clinical programs, particularly those involving complex or specialized patient populations.
• Familiarity with regulatory interactions and documentation requirements for rare disease programs.
• Experience working with IRBs and understanding IRB submission and approval processes.
• Exposure to or involvement in programs progressing toward BLA submission.
• Experience working with cross-functional teams including Clinical Operations, Document Management, and external partners.
• Comfort working in an evolving environment where processes may be refined and improved over time.
• Demonstrated initiative in identifying opportunities to enhance documentation quality, organization, and compliance.

Skills

• Hands-on experience with Trial Master File (TMF) and electronic TMF (eTMF) systems, including implementation and maintenance of TMF specifications.
• Proficiency with Veeva or similar eTMF/clinical documentation platforms.
• Strong administrative skills and experience supporting clinical documentation and study logistics.
• Working knowledge of the drug development process and clinical trial lifecycle.
• In-depth knowledge of International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines.
• Strong understanding of Good Documentation Practices (GDP).
• Knowledge of and adherence to SOPs and compliance with FDA Code of Federal Regulations.
• Experience supporting inspection readiness activities for clinical trials.
• Experience supporting BLA submission-related documentation and activities.
• Experience with site management activities within clinical studies.
• Experience with data review in a clinical trial setting.
• Proficiency with Microsoft Office applications (such as Word, Excel, PowerPoint, and Outlook) for documentation, tracking, and communication.
• Ability to operate effectively in a fast-paced working environment.
• Strong attention to detail and quality focus in documentation and tracking.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills to support internal and external correspondence.
• Demonstrated eagerness to learn and grow within clinical operations.