Job Title : Study Coordinator
Location :
Company : null
Salary :
Open Date : 2024-03-10
Close Date : 2024-07-10

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).

Apply This Job