Medical Officer, Clinical Trials Unit

Medical Officer Clinical Trials Unit

Aga Khan University chartered in 1983 as Pakistans 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 AKUs 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 strong 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 ongoing assessments and follow-ups
• organise and/or administer the informed consent process in conjunction with the principal investigator
• coordinate and provide patient care in compliance with protocol requirements including patient screening recruitment scheduling and study visit procedures
• where relevant disburse investigational products upon written authorisation from the PI and provide appropriate guidance on their administration
• maintain study documentation as per protocol and good clinical practice (GCP) requirements including screening recruitment investigational product accountability enrolment monitoring study visits and adverse or serious adverse events
• review and monitor patients for changes in health status response to investigational products adverse events compliance and concomitant medication use ensuring adherence to protocol requirements
• provide laboratory support services including phlebotomy and collection and handling of specimens using standard techniques
• maintain strict patient confidentiality in accordance with institutional regulations and applicable laws
• schedule and participate in sponsor monitoring visits audits and related activities as required
• assist in preparing and maintaining regulatory and administrative study documents in accordance with applicable regulations institutional requirements and ICH GCP guidelines
• communicate regularly with study investigators regarding patient progress health status and any issues and liaise with sponsors institutional staff faculty and clinical monitors to ensure effective study implementation
• assist the pi in managing and reporting serious adverse events (SAE) and preparing periodic and annual reports for the ethics review committee and sponsors
  facilitate all study start-up and close-out requirements
• review clinical trial protocols and share feedback with supervisors for approval
• draft ethics review committee (ERC) submissions and grant checklists for study review and approval
• initiate institutional review processes to obtain required approvals as per study needs
• draft study budgets and coordinate with the finance department and sponsors for finalization
• manage ongoing invoicing with the finance department in line with study budgets
• facilitate internal and external audits of the unit.

You should have:

• a degree in medicine with relevant clinical experience
• a current registration and be in good standing with the relevant professional association
• at least one year of experience; research experience will be preferred
• excellent clinical skills
• sound working knowledge and proficiency in human clinical trial processes good clinical practice (ICH-GCP) and human research regulatory requirements
• excellent interpersonal and communication skills
• strong critical thinking organizational and management skills
• ability to work effectively in a team demonstrate maturity and work independently with versatility to perform roles such as clinical or nursing care patient services support laboratory or biospecimen processing and data management
• excellent organisational capabilities and ability to manage multiple studies simultaneously
• proficiency in the use of computers and related office software.

Comprehensive employment reference checks will be conducted.