Study Coordinator - Desmond Tutu TB Centre at Stellenbosch University

Duties

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. 

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.

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.

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.

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.

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.    

Finances

• Assisting with monthly billing verification of visits completed at site, and providing feedback to the PI.

Job Requirements    

• 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 driver's licence and own transport.

Recommendation        

• 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).