Open Roles at Setshaba Research Centre

Ref. No: SRC-05-2024

Experience and qualifications:

•  Qualification in any relevant health sciences
•  3 years working in clinical trials as a Study Coordinator or Clinical Research Associate

Key responsibilities include:

•  To facilitate, coordinate and consolidate activities of various sections of the study/clinical trial.
•  Overall management of all aspects of the study/clinical trial
•  Preparation of upcoming studies.
•  Ensure that all study documents /Staff and relevant correspondences are submitted to the local ethics body (IRB/EC) and approvals/ acknowledgements and notifications are obtained before commencement of the study and during the study, as required in consultation with the Principal Investigator as per sponsor/IRB/Ethics Committee and SAHPRA requirements.
•  Facilitate relevant study trainings for study staff and ensure that they are delegated before executing any study related activities.
•  Maintenance of Study Investigator Files, ensure safekeeping of study documents (signed and approved Protocol, Clearance Certificate, Agreement Letters, Investigator’s Brochure, Regulatory approval, Monitoring Reports, Financial Disclosures, etc).
•  Ensure that study staff understand and comply with ICH and GCP guidelines
•  Facilitate study specific SOPs development and training
•  Oversee all administrative and operational activities of the study
•  Ensure that Data Management and Monitoring Queries are resolved within the given time

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Ref. No: SRC-04-2024
Experience and qualifications:

•  Matric and basic knowledge in health
•  Computer literate with good knowledge of Ms Excel and Ms Word
•  Ability to maintain a high degree or professional and confidentiality
•  Effective organisational, communication and interpersonal skills
•  Ability to work independently and as part of a team
•  Ability to work under pressure and meet deadlines
•  Valid GCP Certificate will be beneficial
•  Clinical Research Experience will be beneficial

Key responsibilities:

•  Daily QC, electronic Data Capturing and SDV of CRF’s of participants’ files as per protocol
•  Resolving of internal and external queries
•  Preparation and maintenance of study related documents and participant files Ensure adherence to departmental policies, standard operating procedures (SOPs), quality control guidelines and protocols requirements.
•  Attend to the study related generated CAPAs and perform root cause analysis (RCA)
•  Coordinate with the study Coordinator (SC) and study Principal Investigator (PI) to ensure that discrepancy tasks are completed within the required timelines