- Assist in compiling regulatory submissions such as:
- Clinical trial applications (CTA)
- Import/manufacturing license dossiers
- Ethics Committee submissions
- Product registration documents
- Support in document formatting, referencing, and checklist preparation.
- Perform basic regulatory research and maintain trackers for submissions and approvals.
- Organize and maintain documentation files for audits and inspections.
- Assist in drafting essential clinical trial documents such as protocols, informed consent forms (ICFs), and case report forms (CRFs).
- Help coordinate with investigators, study sites, and ethics committees for submissions and approvals.
- Support study logistics – including site communication, trial master file (TMF) maintenance, and status updates.
- Review and enter clinical trial data under supervision.
- Assist in maintaining compliance with GCP, ICH, and regulatory standards.