Clinical Trial Assistant

About the role

We are seeking a highly organized and detail-oriented Clinical Trial Assistant (CTA) to support the start-up, activation, and ongoing coordination of clinical research sites. This role will work closely with Clinical Research Associates (CRAs), investigators, regulatory teams, and study vendors to ensure clinical trial sites are activated efficiently and remain compliant with regulatory and Good Clinical Practice (GCP) requirements. The ideal candidate will bring strong administrative and clinical research support experience, exceptional organizational skills, and the ability to manage multiple priorities in a fast-paced clinical environment.

Responsibilities

• Clinical Trial Start-Up & Site Activation: Support site feasibility assessments by collecting and reviewing site questionnaires, investigator CVs, site capabilities, and related documentation. Assist with site selection activities and maintenance of study start-up documentation. Track and manage site activation milestones, including essential document collection, IRB/IEC approvals, contract execution, training completion, and Site Initiation Visit (SIV) readiness. Proactively identify and escalate issues that may impact site activation timelines.
• Regulatory & Essential Document Management: Request, review, track, and file essential regulatory documents, including investigator CVs, medical licenses, GCP certifications, financial disclosure forms, and laboratory certifications. Support preparation and submission of regulatory and IRB/IEC application packages. Monitor submission, approval, and renewal statuses. Ensure all study documentation is complete, accurate, audit-ready, and maintained in compliance with GCP and regulatory requirements.
• Trial Coordination & Communication: Serve as an operational point of contact between study sites, CRAs, investigators, regulatory teams, contracts teams, and external vendors. Coordinate study meetings, site communications, and project-related activities. Assist with Site Initiation Visit (SIV) preparation, including agenda development, logistics coordination, material preparation, and site readiness confirmation.
• Contracts, Budgets & Site Support: Coordinate with contracts and budget teams to facilitate execution of confidentiality agreements, clinical trial agreements, and site budgets. Track agreement and budget approval status throughout the study start-up process. Support budget tracking and administrative functions related to clinical trial operations.
• Training & Study Operations: Track completion of required investigator and site personnel training programs. Maintain training records and ensure compliance documentation is current and accessible. Coordinate with cross-functional teams to support investigational product and device logistics, shipment readiness, storage requirements, and site preparation activities.
• Reporting & Data Management: Maintain study start-up trackers and clinical trial management systems. Prepare status reports, metrics, and dashboards highlighting site start-up progress, outstanding action items, activation timelines, and key study milestones. Organize and maintain study-related documents, including protocols, informed consent forms, case report forms, and regulatory submissions.

Requirements

Education: Bachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or a related field. Clinical research certifications such as CCRP, CCRC, or equivalent are preferred.

Experience: Relevant experience supporting clinical research, clinical trials, site management, or study start-up activities preferred. Experience working within a sponsor, CRO, academic research, or healthcare research environment is highly desirable.

Skills

Technical Skills: Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Experience with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), eTMF platforms, or other clinical research technologies. Strong reporting and document management skills.

Knowledge & Competencies: Working knowledge of Good Clinical Practice (GCP), ICH guidelines, and clinical trial regulations. Exceptional attention to detail and commitment to quality. Strong organizational, time management, and multitasking skills. Ability to manage competing priorities in a deadline-driven environment. Excellent written and verbal communication skills. Strong problem-solving skills and ability to collaborate effectively across teams.

Benefits

• Medical
• Dental
• 401(k)
• Direct deposit