Research Associate, Clinical Trials Unit

Location: Karachi

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 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.

Responsibilities:

You will be responsible to:

• develop and maintain a thorough understanding of the study protocol, study instruments and applicable clinical trial requirements
• coordinate study requirements with relevant institutional units and departments, ensuring compliance with AKU policies and procedures
• perform clinical assessment and provide appropriate medical care to study participants, including screening for eligibility, prescribing study medications, monitoring health status and conducting follow-up assessments as required
• coordinate participant screening, recruitment, scheduling, informed consent and study visits in collaboration with the Principal Investigator (PI), ensuring adherence to protocol requirements
• administer or dispense investigational products, where authorised by the PI, provide appropriate guidance to participants on their use, and monitor adherence, response, adverse events and concomitant medication use
• maintain accurate and complete study documentation in accordance with the study protocol, ICH-GCP and applicable regulatory requirements, including participant records, investigational product accountability, adverse event reporting and monitoring documentation
• provide laboratory support, including phlebotomy and collection, handling and processing of required specimens, while maintaining patient confidentiality and adherence to applicable institutional requirements and laws
• support study monitoring, audits and regulatory activities, including preparation and maintenance of study documents, SAE reporting, annual/periodic
  reports, and regular communication with investigators, sponsors, clinical monitors and relevant institutional stakeholders.

Requirements:

You should have:

• an MBBS degree with current registration and good standing with the relevant professional association
• at least one year of relevant experience, preferably in clinical research or clinical trials
• sound working knowledge and proficiency in human clinical trial processes, ICH-GCP and applicable human research regulatory requirements
• excellent interpersonal, communication, critical thinking, organisational and management skills, with the ability to manage multiple tasks across different studies
• demonstrated teamwork, maturity, adaptability and ability to work independently, with versatility to perform across related functions including clinical care, patient services, laboratory and biospecimen processing, and data management.

Comprehensive employment reference checks will be conducted.