Job Title : Study Coordinator
Location :
Company : null
Salary :
Open Date : 2024-03-10
Close Date : 2024-05-10
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, PowerPoint, Excel and Teams; A valid driver's licence and own transport. Recommendation/Aanbeveling Knowledge of national and international regulatory requirements; Experience with 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; Additional language skills in Afrikaans, isiXhosa, or isiZulu (or more than one of these languages).