The Clinical Trial Assistant (CTA) provides day-to-day support for clinical study operations, assisting the clinical project team in the planning, execution, and closeout of outsourced clinical trials. This role ensures compliance with ICH-GCP, regulatory requirements, and internal SOPs while helping to manage documentation, vendor communication, and study logistics across all phases of clinical development.
Responsibilities
- Assist with study start-up activities, including preparation and review of study documents and site/vendor contracts.
- Track subject recruitment, protocol deviations, monitoring visits, and site updates across global studies.
- Maintain and manage essential documents and Trial Master File (TMF); coordinate tracking of clinical supplies.
- Prepare meeting agendas, minutes, and status reports; support communication with CROs, vendors, and sites.
- Participate in quality assurance activities, audits, and inspection readiness tasks.
- Attend study team meetings, site teleconferences, and investigator meetings as needed.
- Support risk assessments and corrective action planning under guidance from Clinical Trial Manager.
Qualifications
- BSc in Biomedical Sciences or a related scientific discipline.
- Minimum 2 years of experience in clinical research or trial coordination.
- Familiarity with clinical trial protocols and good clinical practice (ICH-GCP).
- Strong communication, organizational, and time management skills.
- Experience working with EDC, IWRS, CTMS, or similar clinical systems is a plus.
Senioriy level
Employment type
Job function
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