Study Coordinator

Stellenbosch University | Stellenbosch, Western Cape | ZA

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Serving as a liaison to Sponsor/CRO/Regulatory Authorities/Investigators; Participating in team meetings and conference calls with the Principal Investigator …...

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, thereby ensuring 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 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 in collaboration with relevant site administrative personnel;
  • 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 in collaboration with the laboratory group;
  • Overseeing monthly check of emergency trolley and after use in the event of an emergency;
  • Ensuring that the necessary temperature monitoring is in place 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 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, 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. Quality control and quality assurance
  • Ensuring that knowledge of quality control and quality assurance processes is compliant with trial and site requirements (SOPs);
  • Implementing, maintaining and updating current quality assurance processes;
  • Assessing status of quality at site.

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;
  • 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 start-up 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 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 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. DAIDS / other networks / grant funded studies
  • Informing the clinical research site coordinator of any changes in the site operations;
  • Preparing required documents for trial network 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 in nursing, or a B-degree in medical science or a related field;
  • Active registration with SANC/HPCSA (if applicable);
  • At least three years experience working with IMPAACT, ACTG or TBTC network, or other clinical TB therapeutic trials involving investigational products;
  • At least two 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 and quality assurance processes;
  • In-depth knowledge of compiling documents and making submissions to SAHPRA, the ethics committee, the Departement of Health, the City of Cape Town, and other health authorities;
  • 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 organisation 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, PowerPoint, Excel and Teams;
  • A valid drivers licence and own transport.
Recommendation/Aanbeveling
  • Knowledge of national and international regulatory requirements;
  • Experience of performing quality assurance and regulatory functions for clinical trials, preferably on infectious diseases (TB and HIV in particular);
  • Experience of community-based clinical research on TB, or on TB and HIV;
  • Experience of working with industry sponsored pharmaceutical trials will be advantageous;
  • Additional language skills in Afrikaans, isiXhosa or isiZulu (or more than one of these languages).

Information :

  • Company : Stellenbosch University
  • Position : Study Coordinator
  • Location : Stellenbosch, Western Cape
  • Country : ZA

How to Submit an Application:

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Post Date : 06-07-2024

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