Study Coordinator - Stellenbosch, South Africa - Stellenbosch University

Stellenbosch University
Stellenbosch University
Verified Company
Stellenbosch, South Africa

1 week ago

Thabo Mthembu

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Thabo Mthembu

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Description
Duties/Pligte


  • Administrative
  • Serving as a liaison to sponsors/CRO/regulatory authorities/investigators;
  • Participating in team meetings and conference calls with the Principal Investigator (PI) and subinvestigators 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 closeout 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;
  • 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.
  • 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 uptodate 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.
  • Clinical operations/study start-up/activation
  • Acquiring and maintaining a strong, indepth 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 closeout;
  • 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);
  • Proactively identifying risk factors/challenges for studies and research sites. Developing and implementing contingency plans with the multidisciplinary team;
  • Ensuring that general and studyspecific 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 onsite, and training, delegating and coordinating staff;
  • Liaising closely with clinical, regulatory, administrative, laboratory, pharmacy, data and other relevant teams.
  • 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.
  • 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 Bdegree 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 goaloriented disposition;
  • Excellent computer skills in MS Word, P
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