CRC JD Lead Clinical Investigator Page 1 of 1 THIS DOCUMENT REMAINS THE PROPERTY OF THE FACULTY OF HEALTH SCIENCES University of Cape Town Clinical Research Centre Title Job description Lead Clinical Investigator Date Activities / objectives / tasks Competencies - Leads development of proposals for grant applications, and writes, or contributes to the writing of, study protocols, reports and publications (and other Essential Documentation as required) for the group's clinical research projects. - In depth understanding of drug development and clinical research methodology. - Meticulous attention to detail - Excellent leadership and management, communication and interpersonal skills. - Writing and computer skills. - Time management skills. As above, plus: - In depth Good Clinical Practice knowledge and certification. - Extensive experience as clinical investigator Works in accordance with protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements as regards: - Leading the study team(s) to recruit, screen, enrol and retain adequate numbers of participants, as per the contract. - Overseeing clinical assessments/data collection and/or conducting, recording, reviewing clinical assessments [list] to the satisfaction of monitors, sponsor and regulators/auditors. - Ensures medical well-being of study participants, including appropriate management and reporting of adverse events. As above -Leads the development and maintenance of emergency procedures. - Leads liaison with the Sponsor and other relevant parties regarding clinical, efficacy, safety and scientific issues. - Leads training and supervision of study staff in aspects related to clinical procedures. - Line manager for staff when required. - Input into the development and delivery of relevant academic curricula when required. - Contributes to growth of clinical research capacity within the Department, and/or University. ________________________________ ________________ PI Name/signature Date ________________________________ ________________ Staff name/signature Date - Training or teaching skills. - Attention to detail - Knowledge of appropriate UCT professional development processes. - Communication and interpersonal skills. - Training or teaching skills, including curriculum design. - Attention to detail - Training or teaching skills - Networking skills.