Aga Khan University was established in 1983 as an international university with an objective to promote human welfare in general, and the welfare of the people in the countries in which it operates, by disseminating knowledge and providing instruction, training, research and service in the health sciences, education and such other branches of learning as the University may determine.

Clinical Trials Unit (CTU) is a Department dedicated to develop a center of excellence for high quality and high impact clinical trials both nationally & internationally. It promotes AKU’s vision by providing leadership, consultation and facilitation in different phases of clinical trials in compliance with the International Standards and Good Clinical Practice (GCP) guidelines.

You will be responsible to:

• develop/maintain very good understanding of the study protocol and related study instruments
• liaise and coordinate study requirements with relevant units and departments of the institution, in line with AKU institutional policies
• organize and/or administer the informed consent process to the study subjects 
• coordinate and provide care in compliance with protocol requirements specific to subjects’ screening, recruitment, scheduling, and study visit procedures. 
• administer investigational product upon written authorization from the PI and provide relevant teaching with respect to its administration.
• maintain study documentation as per protocol and GCP requirements (screening, subject recruitment, investigational drug accountability, enrolment, monitoring and study visit, adverse/serious adverse events etc.)
• review/monitor study subjects for changes such as in health status, response to investigational product, adverse events, compliance in use of investigational product, concomitant medication use, protocol compliance
• provide laboratory support services including phlebotomy and collection/handling of required specimens (e.g. stool, urine, nasal swabs) using standard techniques; processing of specimens (shipment handling and preparation where applicable 
• maintain strict data confidentiality according to institutional regulations and applicable law
• schedule and participate in relevant sponsor/other monitoring / audits and activities as directed
• assist in preparing (as relevant) and maintaining regulatory and administrative study documents in accordance with applicable regulations, institutional requirements and ICH GCP guidelines
• communicate with and update the study investigator(s), regularly with respect to study subjects’ progress, health status and any issues; as well, with study sponsors, relevant institutional staff, faculty, and clinical monitors to ensure effective clinical trial implementation and progress
• train and supervise research assistants in completing the study data 
• assist the PI in managing and reporting SAE, annual/periodic reports for Ethics Committee and sponsor 
• facilitate all start-up and close out requirements of the study
• perform pharmacy tasks i.e., drug procurement, dispensing, labelling and log maintenance etc.  in absence of CTU pharmacist.