Senior Research Coordinator, Clinical Trials Unit

Location: Karachi, Pakistan

Indroduction:

Aga Khan University, chartered in 1983 as Pakistan's first private international university, is committed to the provision of education, research, and health care of international standards relevant to Pakistan and the region. The affiliated Aga Khan University Hospital provides state-of-the-art clinical facilities and well-equipped diagnostic services. The University currently has teaching sites in Pakistan, East Africa, the United Kingdom, and Afghanistan, and is a major component of the Aga Khan Development Network.

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.

Clinical Trials Unit (CTU) is a Department dedicated to developing 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.

This is a grant-funded contractual position.

You will be responsible to:

• →coordinate and oversee regulatory and ethical requirements for assigned clinical trials, including ERC applications, renewals, progress and close-out reports, grants checklists, and NBC and DRAP submissions, ensuring timely follow-up and approvals
• →coordinate the preparation and execution of study-related agreements, including clinical trial agreements, data transfer agreements (DTAs), material transfer agreements (MTAs), confidentiality agreements, internal MOUs and other relevant documents
• →review clinical trial protocols from Good Clinical Practice (GCP) and operational perspectives, provide feedback to supervisors and investigators, and ensure compliance with approved protocols, ICH-GCP, institutional policies and applicable regulatory requirements, including timely reporting of adverse events (AEs) and serious adverse events (SAEs)
• →develop and coordinate study-specific budgets for CTU components, monitor trial finances, identify discrepancies and ensure timely communication with the Principal Investigator (PI) and CTU administration
• →develop and implement recruitment plans for assigned studies, oversee participant screening and enrolment, counsel study participants regarding clinical trials, and obtain informed written consent in accordance with approved protocols and ethical requirements
• →coordinate and oversee participant visits, including scheduling and study procedures, while ensuring protocol compliance and adherence to institutional policies and procedures
• →facilitate training and provide guidance to research teams on study protocols, CTU procedures, institutional SOPs, ICH-GCP and other applicable clinical trial guidelines
• →oversee investigational product (IP) management, including dispensing, labelling, storage and accountability, as well as the management of clinical trial supplies
• →supervise specimen management, including collection, storage and shipment, and oversee study data collection, entry and secure storage to ensure data quality and compliance with applicable requirements
• →maintain and update the Trial Master File (TMF) and other essential study documentation, facilitate monitoring visits, track findings and action plans, and ensure study readiness for audits and inspections
• →coordinate with sponsors, CROs, investigators and internal departments, including laboratory, radiology and HIMS, for study meetings, clinical trial services and operational requirements; prepare meeting minutes, monitor study progress and ensure timely follow-up on deliverables and reporting.

Requirements

You should have:

• →a Master’s degree in Epidemiology & Biostatistics, Public Health, Nursing, Education, M.Phil., or an equivalent relevant qualification
• →at least three years of relevant research experience, preferably in clinical research or clinical trials
• →valid Basic Life Support (BLS) and Good Clinical Practice (GCP) certifications, with certification validity within the last two years, for clinical trial-related roles
• →valid International Air Transport Association (IATA) certification, where the role involves specimen handling or shipment
• →sound knowledge of ICH-GCP and institutional, national and international regulations and guidelines governing clinical research
• →excellent communication, interpersonal, organisational and coordination skills.

Comprehensive employment reference checks will be conducted.