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:
- develop and maintain very good 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 assessment and provide medical care to the study subjects i.e. initial subject screening for eligibility, prescribing study medications, ongoing assessment and follow ups
- organise and/or administer the informed consent process in conjunction with the PI
- coordinate and provide patient care in compliance with protocol requirements specific to patient screening, recruitment, scheduling and study visit procedures
- where relevant, disburse investigational product upon written authorisation from the PI and provide relevant teaching with respect to its administration
- maintain study documentation as per protocol and GCP requirements (screening, subject recruitment, investigational drug accountability, enrolment, monitoring and study visit, adverse/serious adverse events etc.)
- review and monitor patients for changes such as in health status, response to investigational product, adverse events, compliance in use of investigational product, concomitant medication use and protocol compliance
- 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 according to institutional regulations and applicable law
- schedule and participate in relevant sponsor or other monitoring, audits and activities as directed
- assist in preparing and maintaining regulatory and administrative study documents in accordance with applicable regulations, institutional requirements and ICH GCP guidelines
- communicate with and update the study investigators regularly with respect to patient progress, health status and any issues; as well, with study sponsors, relevant institutional staff, faculty and clinical monitors to ensure effective clinical trial implementation and progress
- assist the PI in managing and reporting SAE, annual or periodic reports for ethics committee and sponsor
- facilitate all start-up and close-out requirements of the study.
Requirements:
You should have:
- a degree in medicine, or a master's/bachelor’s level qualification in nursing or any relevant health field (e.g. d pharm) with relevant clinical experience
- current registration and good standing with the relevant professional association
- at least one year of experience with an MBBS or three years of clinical work experience in nursing or another health field (e.g. d pharm)
- research experience (preferred)
- excellent clinical skills
- 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/nursing 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.