Study Coordinator

Duties/Pligte

1. Administrative
- Serving as a liaison to Sponsor/CRO/Regulatory Authorities/Investigators.
- Participating in team meetings and conference calls with the Principal Investigator (PI) and sub-investigators for the different protocols, and taking and circulating minutes.
- Setting up Unit and study team meetings as required.
- Providing support to the clinical team to ensure continuity of service and problem resolution.
- Ensuring that study specific and general training is done for all (new) staff and for amendments.
- Ensuring that all study material is correctly archived after the study close-out visit.
- Retaining documentation of vendor qualifications.
- Effective operations and delivery of site activation deliverables within the assigned study.

2. Regulatory
- Engaging with internal and external stakeholders as appropriate, including but not limited to, SAHPRA, USHREC, NHREC, DOH, CCT, TBH and any other regulatory authority as determined by the study/sponsor.
- Maintaining up-to-date knowledge of the relevant ethics committee, SAHPRA and external stakeholders regulations.
- Compiling and submitting submission documents and reports to the ethics committee, SAHPRA and external stakeholders according to their guidelines, SOP's and timelines.
- Submitting AEs, EAEs, SAEs, safety reports, protocol deviations and CAPAs, etc. as per the ethics committee and SAHPRA guidelines, SOP's and timelines.

3. Quality Control and Quality Assurance
- Ensuring that knowledge of quality control and quality assurance processes is compliant with trial and site requirements (SOP's).
- Implementing, maintaining and updating current quality assurance processes.
- Assessing status of quality at site.

4. Quality Management
- Performing and overseeing activities essential to ensure the highest possible quality of work of the clinical trials conducted at the clinical research site.
- Working closely with the quality and assurance manager and the regulatory manager to establish and maintain a good rapport with all clinical research staff.

5. Clinical Operations/Study Start-up/Activation
- Acquiring and maintaining in-depth knowledge of the protocol and its amendments and guiding documents such as the Manual of Operations (MOP), Study Specific Procedures Manual (SSP) and site specific standard operating procedures (SOP's).
- Being up to date with all aspects of the trial - enrolment, retention, major deviations, etc.
- Organising training sessions for study staff, developing training slides, or practical training sessions.
- Developing and maintaining ISF throughout the trial from study startup until study close-out.
- Developing and maintaining source documentation that satisfy the information needed for completing the CRFs.
- Developing CRF templates based on the requirements of the protocol (if indicated).
- Pro-actively identifying risk factors/challenges for studies and research site, and developing and implementing contingency plans with the multidisciplinary team.
- Ensuring that general and study-specific processes comply with the protocol, the MOP and with standard operating procedures (SOP's), and dhering to GCP and regulatory requirements (local and international).
- Completing quality control and quality assurance procedures.
- Setting recruitment goals and timelines in collaboration with the PI and site personnel, and developing recruitment plans and strategies.
- Preparing for monitoring visits and serving as contact person for monitors during the visit.
- Managing relevant members of the research team on-site: training, delegating and coordinating staff.
- Liaising closely with clinical, regulatory, admin, laboratory, pharmacy, data and other relevant teams.

6. Networks/Grant Funded Studies
- Informing the clinical research site coordinator of any changes in the site operations.
- Preparing documents for trial network required submission in a timely manner. Timely review and submission of CSM findings to the regulatory team.

7. Finances
- Assisting with monthly billing verification of visits completed at site and providing feedback to the PI

Job Requirements/Pos Vereistes
- A tertiary qualification as a registered nurse.
- Active registration with SANC.
- At least three years' experience working with clinical TB therapeutic trials, involving investigational products.
- At least three years' experience working as a study coordinator on TB, or TB and HIV, or other infectious disease related randomised clinical trials in children and/or adults, involving an investigational product.
- Actively coordinating at least two clinical trials (one being a randomised clinical trial) as a study coordinator.
- Experience in quality control processes.
- Proven experience of quality assurance and management within randomised clinical trials.
- In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research.