Senior Clinical Trials Coordinator, CTU

aku; Pakistan; On-site; PKR 1,800,000 - 3,000,000; Full time

Job summary

Aga Khan University in Karachi invites applications for a Senior Research Coordinator in the Clinical Trials Unit. You will coordinate regulatory and ethical approvals, manage study documents, and liaise with investigators, sponsors, and departments to advance high-quality trials.

This grant-funded contract requires a Master’s degree and at least three years of clinical research experience, with BLS, GCP and IATA certifications, and strong communication and organizational skills.

Qualifications

• Master’s degree required in Epidemiology & Biostatistics, Public Health, Nursing, Education, or equivalent (M.Phil.).
• At least three years of relevant research experience, preferably in clinical research or clinical trials.
• Valid BLS and GCP certifications, with recent validity within two years.
• Valid IATA certification if the role involves specimen handling or shipment.
• Solid knowledge of ICH‑GCP and applicable regulatory guidelines.
• Excellent communication, interpersonal, organisational and coordination skills.

Responsibilities

• 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.
• Coordinate the preparation and execution of study-related agreements, including clinical trial agreements, data transfer agreements (DTAs), MTAs, confidentiality agreements, MOUs and other documents.
• Review clinical trial protocols from GCP and operational perspectives, provide feedback, and ensure compliance with approved protocols and regulatory requirements.
• Develop and coordinate study-specific budgets for CTU components, monitor trial finances, identify discrepancies and communicate with the PI and CTU administration.
• Develop and implement recruitment plans for studies, oversee screening/enrolment, counsel participants and obtain informed consent accordingly.
• Coordinate participant visits and study procedures, ensuring protocol compliance and adherence to policies.
• Facilitate training and guidance to research teams on study protocols, CTU procedures and ICH-GCP guidelines.
• Oversee investigational product management including dispensing, labeling, storage and accountability; manage supplies.
• Supervise specimen management and data collection, ensuring data quality and secure storage.
• Maintain the Trial Master File and other essential documents; facilitate monitoring visits and audits.
• Coordinate with sponsors, CROs, investigators and internal departments for meetings, progress tracking and reporting.

Skills

Communication skills

Interpersonal skills

Organisational skills

Coordination

Education

Master’s degree in Epidemiology & Biostatistics, Public Health, Nursing, Education, M.Phil.

Job description

Aga Khan University in Karachi invites applications for a Senior Research Coordinator in the Clinical Trials Unit. You will coordinate regulatory and ethical approvals, manage study documents, and liaise with investigators, sponsors, and departments to advance high-quality trials.

This grant-funded contract requires a Master’s degree and at least three years of clinical research experience, with BLS, GCP and IATA certifications, and strong communication and organizational skills.