Clinical Trial Associate

Location: Bala Cynwyd

Job Title:

Clinical Trial Associate

Job Description

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.

+ Coordinate and manage 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.

+ Assist with document filing, organization, and maintenance in the electronic Trial Master File (eTMF), ensuring completeness, accuracy, and inspection readiness.

+ Perform quality reviews of TMF and eTMF content to ensure compliance with SOPs, ICH-GCP, Good Documentation Practices (GDP), and regulatory requirements.

+ Support inspection readiness activities by ensuring documentation is complete, well organized, and easily retrievable for audits and regulatory inspections.

+ 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.

+ Assist with 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.

Essential Skills

+ 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.

+ Demonstrated eagerness to learn and grow within clinical operations.

Additional

Skills & 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…