Study Coordinator at Stellenbosch University

Duties

• 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:
• Formative data collecton (e.g., headcounts and focus group discussions);
• participant recruitment and enrolment;
• specimen collection and storage;
• 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

• 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.