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Clinical Research Assistant

4 months ago

Cape Town, South Africa the Agency Dr. Full time

This is a fantastic opportunity to join a small niche clinical research organisation who are looking to expand the Clinical Project (Admin) team in the South African office. This is a fully office based role.

**JOB PURPOSE**
- To provide administrative support to the Project Director's (PD) for clinical trial activities, acting as a central support person for the CEO in relation to designated project communications, correspondence and associated documentation, with particular emphasis on project administration.

**KEY ACCOUNTABILITIES INCLUDE**
- To ensure the eTMF/TMF are compiled effectively; in a timely manner, to the required standards and are completed to schedule as the study progresses
- Keep track of payments and ensure they are added to the internal data collection system.
- Provide general administrative support to studies, as required, including arranging meetings on behalf of Project Director, compiling agenda and taking minutes.
- Maintain overall clinical studies oversight via the clinical trial tracking system and use this to ensure provision of all required key documentation to support provide monthly updates.

**MAIN TASKS**
- Perform QC of the tracking and filing clinical documents in accordance with GCP and company SOPs.
- Perform periodic checks on the completeness of the study systems, as required, and assists in the final compilation checking and archiving.
- Ensure the timely and full compilation of essential documentation and systems.
- Provide operational support in the administration, scheduling and coordination of activities to assigned clinical studies, which may range from Phase I to Phase IV clinical development (interventional and non-interventional studies).
- Complete professional training to keep up to date with regulation updates and best practices.
- Ensure all Clinical Trial documentation is created, distributed, maintained and tracked, in accordance with SOPs and WPs in order to ensure smooth and timely running of trials.
- Coordinate document assembly and review for study synopses, Investigator Brochures, Request for Proposals (RFP) and other documents as required.
- Develop and maintain functional knowledge of ICH-GCP, SOPs, local regulations, etc. through continued training.
- Arrange internal / external meetings for assigned clinical studies, which may include booking travel, accommodation, catering, etc. for both internal staff and external partners, including compiling Agenda and taking of meeting Minutes.
- Professionally set up project tracking tools and ensure they are used efficiently within the Clinical Development Team.
- Prepare project information for presentation at internal project review meetings, including periodic status reports as requested.

**KNOWLEDGE, SKILLS, and EXPERIENCE**
- Life Sciences degree, nursing qualification or equivalent.
- Experience in a CTA role or in a similar position an EXTRA advantage, including experience with using eTMF/TMF, eCRF, IxRS, and CTMS systems.
- Ability to maintain listings of those responsible for key site activities (e.g. Principle Investigator, Sub-Investigator, CRA Monitor, etc).
- Experience of drafting and maintaining RACIs an advantage.
- Excellent organisation skills, with ability to prioritise and multi-task across several projects.
- An appreciation of ICH GCP and the regulatory requirements for clinical trials.
- Good command of written and spoken English language.

**Job Type**: Temporary
Contract length: 6 months

**Salary**: Up to R15,000.00 per month

**Experience**:

- Clinical Research: 1 year (required)
- project administration: 1 year (preferred)

License/Certification:

- Clinical Qualification (required)

Application Deadline: 2024/01/31