Study Coordinator

4 weeks ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte

1. Administrative
- Serving as a liaison to sponsors/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 ensuring continuity of service and problem resolution;
- Ensuring that study specific and general training takes place for all (new) staff and for amendments;
- Ensuring that all study material is correctly archived after study close-out visits;
- Retaining documentation of vendor qualifications;
- Effective operations and delivery of site activation deliverables within the assigned study.

2. Facility oversight
- Identifying and ordering all supplies needed for the studies and ensuring that they are available for the execution of the study;
- Overseeing that all equipment is calibrated at least once a year or as per product / sponsor guidelines;
- Overseeing maintenance of all clinical and laboratory equipment;
- Conducting monthly checks of the emergency trolley and after use in the event of an emergency;
- Ensuring that the necessary temperature monitoring is done for all relevant items, including, but not limited to, IP and laboratory kits.

3. 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 relevant ethics committee and SAHPRA regulations;
- Compiling and submitting all routine submission documents and reports to the ethics committee and SAHPRA according to their guidelines, SOPs and timelines;
- Submitting AEs, EAEs, SAEs, safety reports, protocol deviations and CAPAs, etc. as per the ethics committee and SAHPRA guidelines, SOPs and timelines.

4. Clinical operations/study start-up/activation
- Acquiring and maintaining a strong, 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;
- Being up to date with all aspects of the trial, including enrolment, retention, major deviations, etc.;
- Organising training sessions for study staff, and 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 satisfies 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 sites. 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 (SOPs). Adhering to GCP and local and international regulatory requirements;
- Personally performing quality control and quality assurance procedures;
- Setting recruitment goals and timelines with the PI and developing recruitment plans and strategies;
- Preparing for monitoring visits and being the contact person for monitors during the visit;
- Managing relevant members of the research team on-site, and training, delegating and coordinating staff;
- Liaising closely with clinical, regulatory, administrative, laboratory, pharmacy, data and other relevant teams.

5. DAIDS/other networks
- Informing the CRS coordinator of any changes in the site operations;
- Preparing documents for any DAIDS/network required submission in a timely manner; Timeously reviewing and submitting the CSM findings to the regulatory team.

6. Finances
- Assisting with monthly billing verification of visits completed at site, and providing feedback to the PI;
- Preparing information for invoicing to the sponsor.

Job Requirements/Pos Vereistes
- A tertiary qualification in nursing or a B-degree in medical science or a related field;
- Active registration with the SANC/ HPCSA (if applicable);
- At least three years' experience working with IMPAACT, ACTG, TBTC and other network trials;
- At least three years' experience working on TB, or TB and HIV trials in children and adults;
- Experience as a study coordinator in clinical trials in TB, or TB and HIV;
- The ability to work accurately according to protocol and related documents, SOPs and regulatory requirements;
- The ability to work independently, or in a team environment as a member of an interdisciplinary team;
- Sound interpersonal skills;
- Strong organisational and prioritisation skills;
- Excellent written and verbal communication skills in English;
- The skills to solve problems independently and effectively;
- A goal-oriented disposition;
- Excellent computer skills in MS Word, P

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