• Trial Coordination Support. • Coordinate with sponsors, CROs (Contract Research Organizations), and other stakeholders to ensure smooth execution of clinical trials; • Provide support to PIs to ensure patient recruitment, enrolment, and follow-up processes; and, • Monitor progress, resolve issues, and ensure data integrity and accuracy. • Clinical trial support. • Support development of risk-based monitoring plan; • Conduct pre study/site selection visits, site initiation visits including participating in the activation/green light process, interim visits and close-out visits; • Provide on-site monitoring according to the clinical trial protocol, monitoring plan and Unit procedures; • Review informed consent process and documentation at trial site; • Review source data, Serious Adverse Events (SAE) and all trial related documentation for accuracy, contemporaneity and completeness; • Positively and effectively communicate and discuss monitoring findings with investigator teams; • Facilitate the development and implementation of corrective action plans; • Prepare accurate and timely monitoring reports and follow-up letters; • Follow-up issues and corrective actions consistently, effectively and timely; • Proactively engage research teams to pre-emptively identify and address areas of concern; • Deliver a range of remote monitoring activities, including review of trial data; • Critically review monitoring reports for trials monitored by external parties, including acting as a point of contact for external monitors; • Participate in internal and external audits/inspections; • Participates in the maintenance of the Investigator Site File (ISF) and Trial Master File (TMF) where applicable; • Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for treatment and informed consent storage and other areas; • Confirm investigational products are handled, stored and used in line with the protocol, Investigational Product (IP) Manual and Unit Standard Operating Procedures (SOPs); • Ensure samples and records are stored appropriately with adequate environment controls; and, • Participate in reciprocal monitoring of studies conducted at the Unit and collaborating institutions. • Quality Assurance. • Conduct regular audits and quality checks to ensure adherence to SOPs and regulatory requirements; • Prepare sites for monitoring, audits, and inspections; and, • Implement and assess corrective actions for any identified issues or non-compliance. • Regulatory Compliance. • Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, and other regulatory guidelines; • Maintain up-to-date knowledge of relevant regulations and ensure the clinic’s practices adhere to them through training and other procedures; • Guide PIs to prepare and submit necessary documentation for ethics and regulatory approvals; and, • Guide PIs to maintain essential documents. • Communication and reporting. • Maintain clear and effective communication with investigators and other key stakeholders; and, • Prepare and present regular reports on trial progress, operational issues, and performance metrics. • Clinical trial support. • Act as a focal point for communication with the trial team for Unit sponsored trials and contact site staff regularly; • Register clinical trials on public databases and update entries, as required; • Ensure that SAEs and other reportable events are well documented and appropriately reported and followed up; • Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for Unit Sponsored trials, as applicable; • Oversee that Unit sponsored studies are well managed and delivered to expected timelines;

• Bachelor’s in a health related field such as Nursing, Public Health, Health Service Management, Biomedical Laboratory Science, Pharmacy, Medicine and Surgery or equivalent; • Masters in Clinical Trials or Post Graduate Diploma in Clinical Trials; • Training in clinical trial monitoring and or certification; • Training in Human Subjects Protection; • Training in Good Clinical Practice; • Should possess at least 3 years of experience in conducting research; • At least 3 years of experience in conducting clinical trial monitoring; • Experience in conducting trainings including GCP, SIV trainings etc.; • Experience in auditing or being audited by sponsor and regulatory bodies; • Comprehensive understanding of local and international research guidelines and regulations across multiple disciplines; • Should demonstrate knowledge and experience with research methods; • Enthusiastic about research; and, • Excellent communication skills demonstrating both open and clear communication.