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Study Coordinator

3 weeks ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte
- Ensuring compliance with the health research ethics committee (HREC), regulatory requirements, GCP, standard operating procedures (SOPs), and sponsor requirements;
- Establishing and maintaining knowledge of relevant study and site related regulatory requirements;
- Study protocol implementation and ensuring that the clinical research and activities are performed in accordance with the approved protocol;
- Managing the research team: training, delegating and coordinating members of the study team regarding protocol implementation and regulatory requirements;
- Producing satisfactory regulatory and other required study reports and associated documentation in accordance with timelines, SOPs and study-specific requirements;
- Engaging with internal and external stakeholders, including community groups, as required;
- Preparing and submitting regulatory submissions in accordance with the QA and regulatory team;
- Maintaining up-to-date investigator site files;
- Study Administration: performing quality control of the clinical trial procedures conducted at the research unit, and ensuring accurate and timely data capturing, including day-to-day management of study related activities;
- Gathering, evaluating, organising, managing and collating information in a variety of formats, including basic analyses and reports for PI's, Sub'I's and QA and regulatory managers;
- Liaising closely with clinical, laboratory, data and other relevant teams;
- Liaising with study participants and government health facilities (e.g., TB and HIV clinics, as well as hospitals) as required;
- Overseeing participant recruitment and retention as per protocol requirements;
- Supporting overall operations at the research unit as required.

Job Requirements/Pos Vereistes
- A relevant undergraduate degree in life science, nursing or pharmacy;
- Valid registration with the SANC, the HPCSA or the SAPC, as applicable (if nurse, medical doctor, pharmacist, or scientist);
- At least two years' experience as a clinical trial study coordinator (knowledge of clinical trials, site processes, SOP's, quality control and quality assurance, etc.);
- Two years' study administration and data entry experience/knowledge;
- Knowledge and experience of South African clinical trial regulatory and ethical requirement;
- Knowledge of Good Clinical Practice (GCP) guidelines;
- Attention to detail and strong decision-making skills;
- The ability to work accurately according to procedures, rules and regulations;
- The ability to work independently as a member of an interdisciplinary team;
- Document and resource management;
- Sound interpersonal skills;
- Good written and verbal communication skills in English, at a minimum;
- The ability to solve problems independently and effectively;
- A goal-oriented disposition;
- A valid driver's licence and own transport.

Recommendation/Aanbeveling
- Prior research experience, ideally with an international clinical network (e.g. IMPAACT, ACTG, TBTC, and other) trials;
- Specific experience in TB and/or paediatric related clinical research;
- A GCP certificate;
- Additional language skill in Afrikaans or isiXhosa.