Study Coordinator
2 weeks ago
Duties/Pligte
- Ensuring compliance with ethics (HREC) regulatory requirements, GCP, standard operating procedures (SOPs), and sponsor requirements;
- Overseeing trial implementation on site;
- Establishing and maintaining knowledge of relevant study and site related regulatory requirements;
- Training members of the study team regarding protocol implementation and regulatory requirements;
- Producing satisfactory regulatory and other required reports and associated documentation in accordance with timelines, SOPs and study-specific requirements;
- Maintaining up-to-date Investigator Site Files;
- Completing and presenting protocol-related documentation to relevant investigators for submission to the appropriate regulatory agencies;
- Engaging with internal and external stakeholders, including community groups, as required;
- Maintaining and updating relevant progress reports regarding amendments, safety events, recruitment status, etc., for the principal investigators to submit to ethics and regulatory committees as well as to the sponsors;
- Proactively identifying risk factors for studies and the research site. Developing and implementing contingency plans with a multidisciplinary team;
- Study Administration: Performing quality control of the clinical trial procedures conducted at the research unit and ensuring accurate and timely data capturing;
- Developing and maintaining records of research activities, including case report forms, drug dispensation records, pill counts, laboratory documentation, regulatory documents and source documents;
- Gathering, evaluating, organising, managing and collating information in a variety of formats, including basic analyses and reports;
- Managing the research team: training, delegating and coordinating staff;
- Liaising closely with clinical, laboratory, data and other relevant teams;
- Liaising with study participants and government health facilities (e.g. TB and HIV clinics and 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 tertiary qualification in nursing, medical, science or a related field;
- Active registration with SANC/ HPCSA (if applicable);
- Experience of clinical research, preferably as study coordinator;
- 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 of working in a team environment;
- Strong organisational 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.
Recommendation/Aanbeveling
- Knowledge of national and international regulatory requirements;
- Experience of performing quality assurance and regulatory functions for clinical trials, preferably on infectious diseases (TB and HIV in particular);
- Experience of community-based clinical research on TB, or on TB and HIV;
- Additional language skills in Afrikaans, isiXhosa or isiZulu (or more than one of these languages).
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