Clinical Trial Associate
About The Position
The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Team throughout clinical trial start-up, maintenance, and close-out, as well as vendor management. The role operates in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable clinical trial regulations. The CTA supports study documentation and tracking, regulatory and financial submissions, Trial Master File (TMF) activities, and coordination with study teams and vendors. The position may also contribute to quality control and development of study-related documents, vendor communication, and SOP updates.
Requirements
- Bachelor’s degree in a related or similar field.
- At least one year of relevant clinical trial experience in the pharmaceutical and/or biotechnology industry.
- Prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements, and clinical trial operations.
- Strong organizational, communication, and administrative skills.
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Ability to oversee multiple tasks and meet deadlines in a dynamic environment.
- Good organization, documentation, and interpersonal skills.
- Ability to work independently and collaboratively.
- Strong attention to detail.
Responsibilities
- Review, format, and finalize clinical protocols and other key study documents, including reports and Study Master ICF Templates.
- Provide administrative support, including document review and formatting, task follow-up, and project timeline updates.
- Develop and maintain study tools and trackers, such as study contact lists, vendor contract tracking, site visit report completion, and sample management.
- Route and track approval forms for essential study documents, including informed consent forms and study plans.
- Submit study agreements, contracts, and budgets for assigned studies to the finance team.
- Request country-level clinical trial liability insurance certificates for assigned studies.
- Provide Regulatory Affairs with copies of 1572/Investigator Statement of Compliance and Financial Disclosures.
- Collaborate with the eTMF Owner to draft and finalize the eTMF Plan and Expected Document Lists (EDLs).
- Oversee TMF filing, including review and reconciliation activities.
- Ensure proper filing and review of Site Essential Documents during study start-up, maintenance, and close-out.
- Participate in department and clinical trial team meetings and collaborative efforts, including protocol development, CRO selection, and departmental initiatives.
- Review monitoring reports for clinical sites across studies.
- Perform QEVs at clinical sites when necessary.
- Provide initial and ongoing study information to support clinical trial registration, such as ClinicalTrials.gov.
- Execute ad hoc study-related administrative tasks assigned by the Study Lead.
- Recommend SOP modifications when needed to improve compliance or efficiency.
- Comply with assigned SOPs and applicable plans, guidelines, and standards.
- Perform quality control of study-related documents, including checks for formatting, spelling, grammar, accuracy, and consistency, as needed.
- Contribute to developing study-related documents, including study plans, templates, investigator site file materials, and newsletters, as needed.
- Serve as a point of contact for clinical vendors when delegated by the Study Lead.
- Participate in SOP development and revisions, as needed.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
