Research Associate, Clinical Trials Unit

Research Associate, Clinical Trials Unit

Location: Karachi, Pakistan.

Aga Khan University chartered in 1983 as Pakistan's first private international university, is committed to the provision of education, research, and health 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.

You Will Be Responsible To:

• develop and maintain a sound understanding of the study protocol and related study instruments
• liaise and coordinate study requirements with relevant units and departments of the institution, in line with AKU institutional policies
• perform clinical assessments and provide medical care to study subjects, including initial screening for eligibility, prescribing study medications, and conducting ongoing assessments and follow-ups
• organise and/or administer the informed consent process in conjunction with the principal investigator (PI)
• coordinate and provide patient care in compliance with protocol requirements related to screening, recruitment, scheduling and study visit procedures
• disburse investigational product upon written authorisation from the PI, where relevant, and provide appropriate guidance on its administration
• maintain study documentation as per protocol and GCP requirements, including screening, subject recruitment, investigational drug accountability, enrolment, monitoring and study visits, adverse/serious adverse events, etc.
• review and monitor patients for changes in health status, response to investigational product, adverse events, compliance in product use, concomitant medication use and protocol adherence
• provide laboratory support services including phlebotomy and collection/handling of required specimens (e.g. stool, urine, nasal swabs) using standard techniques
• maintain strict patient confidentiality in accordance with institutional regulations and applicable law
• schedule and participate in sponsor or other monitoring, audits and related activities as required
• assist in preparing and maintaining regulatory and administrative study documents in line with applicable regulations, institutional requirements and ICH GCP guidelines
• communicate regularly with study investigators on patient progress, health status and issues, as well as with study sponsors, institutional staff, faculty and clinical monitors to ensure effective trial implementation and progress
• assist the PI in managing and reporting SAE, and in preparing annual or periodic reports for the ethics committee and sponsor
• facilitate all start-up and close-out requirements of the study.

You Should Have:

• mbbs degree with relevant clinical experience
• must have a valid PMDC licence
• at least one year of clinical work experience
• 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, organisational and management skills
• the ability to work as part of a team, demonstrate maturity, work independently, and be versatile in a variety of roles such as clinical care, patient services support, lab/bio-specimen processing, and data management
• strong organisational capabilities and the ability to manage a diverse set of tasks for multiple studies simultaneously
• proficiency in the use of computers and related office software.

Comprehensive employment reference checks will be conducted.