Study Coordinator

6 days ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte- Ensuring compliance with ethics (HREC) regulatory requirements, GCP, standard operating procedures (SOPs), and sponsor requirements;- Establishing and maintaining knowledge of relevant study and site related regulatory requirements;- Producing satisfactory regulatory and other required reports and associated documentation in accordance with timelines, SOPs and study-specific requirements;- Overseeing study implementation across four health facilities within study timelines as per protocol requirements:
o Formative data collecton (e.g., headcounts and focus group discussions);

o participant recruitment and enrolment;

o specimen collection and storage;

o quantitative and qualitative data collection (e.g., surveys and in-depth interviews).Managing research assistants: on-going training, and coordination;- Liaising closely with clinical, laboratory, data and other relevant teams;- Liaising with study participants, health facility staff and any other internal and external stakeholders, including community groups;- Maintaining and updating relevant progress reports regarding amendments, safety events, recruitment status, etc., for the study investigators;- Pro-actively identifying any risk factors for study implementation or study site;- Developing and implementing contingency plans with the multidisciplinary team;- Maintaining records of research activities, including informed consent forms, case report forms, laboratory documentation, regulatory documents and source documents;- Gathering, evaluating, organising, managing and collating information in a variety of formats, including basic analyses and reports;- Maintaining up to date Investigator Site Files.

Job Requirements/Pos Vereistes
- A nursing, medical, science (or related field) tertiary qualification;
- Active registration with the SANC / HPCSA (if applicable);
- Experience in clinical or operational research;
- Experience in project management, preferably within a research environment;
- The ability to work accurately according to procedures, rules and regulations;
- The ability to work independently as a member of an interdisciplinary team;
- Sound interpersonal skills and experience with working in a team environment;
- Strong organisation and prioritisation skills;
- Good written and verbal communication skills in English;
- The skills to solve problems independently and effectively;
- A goal-oriented disposition;
- Computer literacy (MS Word, PowerPoint and Excel);
- A valid driver's licence and own transport;
- The ability to attend all the necessary project trainings, meetings, and calls.

Recommendation/Aanbeveling
- Experience of working in primary healthcare facilities, as a health provider or researcher;
- Good understanding of the TB programme in the Western Cape province;
- Additional language skills in Afrikaans and / or isiXhosa (or more than one other official South African language).

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