Study Coordinator

Department Description/Departement BeskrywingFaculty of Medicine and Health SciencesDepartment of Paediatrics and Child HealthDesmond Tutu TB Centre (DTTC)Study Coordinator (Job Level 8)(Two-year contract with the option of benefits)Ref.
TGB12/329/1224The Desmond Tutu TB Centre (DTTC), Department of Paediatrics and Child Health in the Faculty of Medicine and Health Sciences at Stellenbosch University (SU), requires the services of an experienced clinical trial study coordinator to assist with the implementation of internationally funded multi-site network and pharmaceutical clinical trials for treatment and prevention of TB and HIV.
Networks may include IMPAACT, ACTG, TBTC and others.The position will be based at the DTTC's clinical trial site in Kuils River.
The incumbent will work with a multidisciplinary team at Kuils River and with members of the DTTC's core team based at the University's Tygerberg campus.There is an option to extend the contract based on availability of funding.The purpose of the position is to coordinate TB trial activities at site and institutional level to ensure efficiency and protocol compliance.
This includes clinical trial coordination and oversight and quality assurance duties.Duties/PligteAdministrativeServing 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 to ensure 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 the study close-out visit.Retaining documentation of vendor qualifications.Effective operations and delivery of site activation deliverables within the assigned study.RegulatoryEngaging 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, SOP's and timelines.Submitting AEs, EAEs, SAEs, safety reports, protocol deviations and CAPAs, etc.
as per the ethics committee and SAHPRA guidelines, SOP's and timelines.Quality Control and Quality AssuranceEnsuring that knowledge of quality control and quality assurance processes is compliant with trial and site requirements (SOP's).Implementing, maintaining and updating current quality assurance processes.Assessing status of quality at site.Quality ManagementPerforming and overseeing activities essential to ensure the highest possible quality of work of the clinical trials conducted at the clinical research site.Working closely with the quality and assurance manager and the regulatory manager to establish and maintain a good rapport with all clinical research staff.Clinical Operations/Study Start-up/ActivationAcquiring 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 (SOP's).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 startup 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 site, and 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 (SOP's), and 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.Networks/Grant Funded StudiesInforming the clinical research site coordinator of any changes in the site operations.Preparing documents for trial network required submission in a timely manner.Timely review and submission of CSM findings to the regulatory team.FinancesAssisting with monthly billing verification of visits completed at site and providing feedback to the PI.Job Requirements/Pos VereistesA tertiary qualification as a registered nurse.Active registration with SANC.At least three years' experience working with clinical TB therapeutic trials, involving investigational products.At least three 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 processes.Proven experience of quality assurance and management within randomised clinical trials.In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research.Experience in auditing processes and procedures, including the development of plans for corrective and preventive actions.Experience in supporting third party audits and monitoring visits.In-depth knowledge of compiling documents and of submitting to SAHPRA, ethics committee, Department of Health, City of Cape Town and other health authorities.The ability to work accurately according to protocol and related documents, SOP's 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 (MS Word, PowerPoint, Excel and Teams).A valid driver's licence and own transport.Recommendation/AanbevelingKnowledge of national and international regulatory requirements.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).How To Apply/Hoe Om Aansoek Te DoenStellenbosch University is committed to employment equity (EE), and appointments will be made in line with the EE plan for the specific environment as well as the institutional EE Plan of the University.Stellenbosch University reserves the right not to make an appointment.Your application, comprising a comprehensive curriculum vitae (including the names and email addresses of at least three referees), must reach the University before or on the closing date of the advertised post.APPLY ONLINE BY USING THE APPLY NOW LINK AT THE TOP RIGHT-HAND CORNER OF THE SPECIFIC VACANCY PAGE.The University reserves the right to investigate qualifications and conduct background checks on all candidates.The Occupational Health and Safety Act requires people in occupations that entail potential exposure to certain hazards (such as, but not limited to: noise, hazardous chemical substances and hazardous biological agents) to be subjected to medical screening, to determine their fitness to work in the said occupations.Should no feedback be received from the University within four to six weeks of the closing date, kindly accept that your application did not succeed.Enquiries/NavraeEnquiries regarding this post: Sterna Brand on 021 938 9755, or atEnquiries regarding remuneration/benefits, as well as technical assistance with the electronic application process: Human Resources Client Services Centre on 021 808 2753 (Stellenbosch) / 021 938 9636 (Tygerberg).Currency ZARCommencement Date 01-Feb-2025Closing Date 15-Jan-2025Amount of TravelWork At Home
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