Study Coordinator

In brief

**Overview** The Desmond Tutu Health Foundation is seeking a Study Coordinator to oversee the comprehensive management and execution of health-related studies. This role is pivotal in ensuring the smooth and successful operation of clinical trials from start-up to archiving, adhering strictly to protocols, standard operating procedures (SOPs), and ethical guidelines. The coordinator will be responsible for meticulous documentation, compliance assurance, operational oversight, and fostering positive relationships with staff, participants, and external stakeholders, including international partners. The position may involve managing after-hours communications and contributing to a 24/7 participant support system on a rotational basis. **What you will do** * **Study management and implementation:** * Implement and execute studies and related protocols and SOPs to ensure smooth and successful running of studies from start up to archiving. * Maintain investigator site files including Ethics communication, all versions of protocol and consent forms, staff details etc. and documentation. * Ensure all staff have current CVs, GCP certification, and professional registrations. * Assist with regulatory submissions. * Prepare study documentation required for study visits and study operation (paper source documents, logs etc.). * Responsible for staff training including documentation and oversight, data collection, and other administrative tasks. * Ensure that QC/QA processes are followed. * Ensure that study specific lab and pharmacy documentation is complete. * Prepare for monitoring visits. * Ensure that the site is audit and inspection ready. * Work with the monitors to resolve queries timeously. * Ensure site and study SOPs are current and staff are trained. * Ensure compliance with SOPs. * Monitor recruitment and ensure recruitment and retention targets are met timeously and maintained. * Compile study progress reports for site and study meetings. * Document protocol deviations and implement CAPAs when necessary. * Ensure that all necessary equipment and consumables needed for conduct of the study are ordered, delivered, and maintained. * **Communication:** * Maintain a positive relationship between site staff; between staff and participants and staff and any external stakeholders. * Maintain a positive relationship with monitors and sponsor project managers. * Attend calls with study stakeholders. * Be available for after-hours calls at a reasonable hour and frequency due to collaboration with international partners. * Participate in rotational monitoring of the site’s study phone to ensure 24/7 participant access to clinical staff. * Clearly communicate study successes and challenges with the Principal Investigator (PI) and other site leadership. * **Site Related Activities:** * Participate in site meetings and take minutes when required. * Adhere to all site operating procedures. * Manage participant reimbursement as required. * Work with line managers of other staff to ensure study and site cohesion. * Promote the site and maintain the site’s reputation with visitors, stakeholders and colleagues. * Assist colleagues with communication with support services (e.g., IT, HR) to ensure smooth operation of the site. * **Line Management (if required):** * Line-manage allocated staff (e.g., counsellors) and manage timesheets and leave forms. * Conduct performance assessments of relevant staff and provide constructive feedback as per DTHF HR policies. * Communicate with and assist HR department with regards to HR related processes. **Requirements (from the original advert)** * Degree in Health-related tertiary qualification * At least 3 years’ experience in clinical research * At least 3 years’ experience as a Study Coordinator * Knowledge of HIV /TB /STI’s * Knowledge of quality control, activities, systems and processes QA/QC * Knowledge of ethical and regulatory compliance procedures and documentation required for clinical trials * Knowledge of data quality assurance and quality control skills, including experience drafting standard operating procedures for clinical trials * Study monitoring and evaluation skills, including regular report generation. * Good work ethics * Willingness to line manage counsellors if required * Excellent communications skills verbal and written * Planning and organizing skills * Strong problem-solving skills * Strong decision-making skills * Attention to detail * Ability to work independently and as part of a team * Ability to work under pressure * Valid Driver’s License and own transport **Who should apply** An experienced professional with a health-related tertiary qualification and a minimum of three years' experience in clinical research, including at least three years specifically as a Study Coordinator. The ideal candidate will possess in-depth knowledge of HIV/TB/STIs, clinical trial ethical and regulatory compliance, quality control and assurance (QA/QC) processes, and data quality skills, including SOP drafting. They should demonstrate strong capabilities in study monitoring, evaluation, planning, organizing, problem-solving, and decision-making. Essential attributes include excellent verbal and written communication, strong work ethics, meticulous attention to detail, and the ability to work both independently and collaboratively under pressure. A willingness to line-manage counsellors if required is also necessary, along with a valid driver’s license and personal transport. **Deadline** Not specified **Reference** Original posting: https://www.myjobmag.co.za/job/study-coordinator-desmond-tutu-health-foundation-1 Source: myjobmag

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• At least 3 years of experience.

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