<p>CRC JD Clinical Research Manager Page 1 of 2 THIS DOCUMENT REMAINS THE PROPERTY OF THE FACULTY OF HEALTH SCIENCES</p><p>University of Cape Town Job description Clinical Research Centre</p><p>Title Clinical Research Manager Date Activities / objectives / tasks Competencies - Works with the head of the research - General management, financial and administration skills group as regards developing and - Knowledge of appropriate UCT HR and professional development processes. implementing the group's strategic direction.</p><p>- Oversees systems for the day-to-day operation of the group (e.g. office space, equipment, consumables, access control, storage and records, finances).</p><p>- Performs HR functions as required (developing capacity, and recruitment, job descriptions, induction of new staff).</p><p>- Line manager for group staff where required. - Develops and monitors adherence to - Understanding of drug development processes and clinical research/trial a quality management plan for the methodology group's clinical research, including - Good Clinical Practice knowledge/certification and clinical research Standard Operating Procedures experience (SOPs), training plans, job - Leadership and project management experience and skills descriptions, monitoring and audit. - Attention to detail - Communication and interpersonal skills - Leads development of - Writing and computer skills processes/tools, and supports study - Time management skills team(s), as regards: - Training/teaching skills  Project management  Submission of regulatory and ethical submissions  Preparation, maintenance, and archive of Essential Documents  Development and maintenance of staff schedules and training in study processes/SOPs  Sourcing and maintenance of study venue, equipment and consumables  Recruitment, screening, enrolment and retention of adequate numbers of participants  Timely and accurate data 2 collection and reporting, including of adverse events (AEs)  Quality control  Budgets and finances</p><p>- Works in accordance with protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements as regards performing a study project management role, where required (including conduct of study assessments and data recording, if necessary, according to experience and qualification and delegated role). - Conducts and publishes own - Understanding of relevant methodologies research (if relevant).</p><p>______PI Name/signature Date ______Staff name/signature Date</p><p>2</p>