Introduction:
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. The Department 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.
As an equal opportunity employer, AKU believes in promoting a diverse and inclusive culture and is committed to adopt appropriate standards for safeguarding and promoting a respectful relationship with and between diverse workforce of its faculty, staff, trainees, volunteers, beneficiaries, wider communities, and other stakeholders with whom it works, including children and vulnerable adults and expects all employees/trainees and partners to share this commitment.
The Aga Khan University invites applications for the position of Senior Research Coordinator, Clinical Trials Unit.
Responsibilities:
You will be responsible to:
- initiate and execute all institutional and regulatory approvals of CTU trials
- submit and follow up on regulatory documents, including ERC applications, renewals, progress and close-out reports
- submit and follow up on grant checklists, NBC, and DRAP submissions
- manage study agreements such as CTAs, DTAs, MTAs, confidentiality agreements, and internal MOUs
- report adverse events (AEs) and serious adverse events (SAEs) to relevant authorities including sponsors, ERC, CMO, NBC, and DRAP
- review study protocols from a GCP and operational perspective and share feedback
- draft CTU budgets and coordinate with stakeholders for review and approval
- independently organize and manage multiple studies with minimal supervision
- develop and implement recruitment plans for assigned studies
- train research teams on protocols, institutional and CTU SOPs, and clinical trial guidelines
- counsel study participants and obtain written consent
- schedule and manage study visits in line with institutional policies
- oversee IP labeling, dispensing, storage, and accountability
- supervise biospecimen collection, storage, and shipment
- maintain and update trial master files
- supervise data collection, entry, and storage in compliance with ICH-GCP and other guidelines
- manage logistics and ensure timely replenishment of clinical supplies
- liaise with sponsors, departments, CROs, and investigators from feasibility review to trial close-out
- coordinate meetings with sponsors and CROs and draft minutes
- report study progress and safety events within deadlines
- facilitate monitoring visits and develop corrective action plans
- track trial finances and report discrepancies to PI and CTU administrative staff
- arrange and coordinate procurement of routine clinical, diagnostic, and support services
- liaise with internal departments such as laboratory, radiology, and HIMS for operational support
Requirements
You should have:
- master’s degree in public health, epidemiology, nursing, education, or equivalent, with 3–4 years of research experience
- registered with relevant professional body; valid BLS, GCP (within 2 years), and IATA certification (if applicable)
- strong knowledge of ICH-GCP and relevant regulatory guidelines
- excellent communication, interpersonal, and organizational skills