Research Coordinator, Clinical Trials Unit
Introduction
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 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 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.
This is a short-term grant-funded contractual position.
Responsibilities
You will be responsible for:
- developing and maintaining a strong understanding of the study protocol and related instruments
- liaising and coordinating study requirements with relevant institutional units and departments in alignment with AKU policies
- organizing and administering the informed consent process in collaboration with the Principal Investigator (PI)
- coordinating and delivering patient care in accordance with protocol requirements, including screening, recruitment, scheduling, and study visit procedures
- disbursing investigational products (where applicable) upon written authorization from the PI and providing necessary guidance on their administration
- maintaining study documentation in compliance with protocol and Good Clinical Practice (GCP) requirements, including records for screening, recruitment, investigational product accountability, enrollment, monitoring, adverse events, and study visits
- monitoring patients for health status changes, response to investigational products, adverse events, compliance with treatment, and protocol adherence
- providing laboratory support services, including phlebotomy and collecting/handling specimens (e.g., stool, urine, nasal swabs) using standard techniques
- ensuring strict patient confidentiality in line with institutional regulations and applicable laws
- scheduling and participating in sponsor meetings, monitoring visits, audits, and other study-related activities as required
- assisting in the preparation and maintenance of regulatory and administrative study documents in compliance with applicable regulations, institutional requirements, and ICH GCP guidelines
- communicating regularly with study investigators, sponsors, institutional staff, faculty, and clinical monitors to provide updates on patient progress, health status, and study-related issues
- drafting and submitting serious adverse event (SAE) reports and periodic/annual reports to regulatory bodies and sponsors
- facilitating all start-up and close-out activities for the study.
Requirements
You should have:
- a degree in medicine, or a master’s/bachelor’s degree in nursing or any relevant health field (e.g., D Pharm) with relevant clinical experience
- current registration and be in good standing with their professional association
- at least two years of research experience with an MBBS or three years of clinical work experience in nursing or other fields (e.g., D Pharm)
- a sound working knowledge and proficiency in human clinical trial processes, good clinical practices (ICH-GCP), and human research regulatory requirements
- excellent interpersonal and communication skills
- strong critical thinking abilities, organizational and management skills
- excellent organizational capabilities and the ability to handle a diverse set of tasks for multiple studies simultaneously.
Comprehensive employment reference checks will be conducted.
