Pharmacist, Clinical Trials Unit

Pharmacist, Clinical Trials Unit

Location: Karachi, Pakistan

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 grant-funded contractual position.

Responsibilities:

You will be responsible to:

• review clinical trial protocols, relevant SOPs, investigator brochures (IB), and other study documents
• liaise with principal investigators and/or trial coordinators for investigational product (IP) management and promptly report any discrepancies or deviations
• prepare and dispense investigational products as per protocol, institutional, and regulatory requirements
• maintain inventory for clinical investigational drug trials, including ordering, replacing, and returning study materials as required
• maintain appropriate logs for dispensing, storage, returns, and temperature monitoring, ensuring accuracy and integrity as per protocol requirements
• store investigational products as per specified conditions and maintain cold chain and temperature records
• monitor pharmacy activities daily to ensure adherence to study protocols and dispensing procedures
• maintain pharmacy trial documentation, including dispensing logs, temperature logs, and accountability records, and report any ethical concerns or deviations to the supervisor
• coordinate with sponsors, EPI centre, MMD, and warehouse for study drug procurement and develop procurement plans accordingly
• replenish study drugs as per the planned schedule
• communicate with and train staff involved in clinical investigational drug trial management
• participate in the orientation and training of new employees, pharmacy trainees, and interns
• provide drug-related information to physicians, nurses, and other healthcare professionals regarding investigational products
• attend and contribute to interdisciplinary team meetings related to clinical trials
• support randomisation processes as per protocol, if required
• complete and maintain reports, including incident reports and adverse drug reaction reports
• liaise with CTU, department of pharmacy, principal investigators, clinical trial coordinators, EPI, MMD, and trial sponsors
• consult with pharmacy personnel to obtain required expertise in support of investigational drug trials
• perform cross-functional duties including measuring blood pressure, temperature, height, weight, and pulse rate.

Requirements:

You should have:

• bachelor’s degree in pharmacy with appropriate clinical/pharmacy experience
• valid registration with the Pharmacy Council of Sindh with at least two years of experience in a hospital-based pharmacy or related environment
• research and clinical experience will be considered an added advantage
• strong communication and interpersonal skills
• proficiency in the use of computers and MS Office applications
• proficiency in the written and verbal English language.

Comprehensive employment reference checks will be conducted.