Senior Research Coordinator, Clinical Trials Unit

Senior Research Coordinator, Clinical Trials Unit

Entity: Aga Khan University

Location: Karachi, Pakistan

Introduction:

The Aga Khan University was found in 1983 as Pakistan’s first private university, Aga Khan University is a not-for-profit institution and an agency of the Aga Khan Development Network. Starting in 2000, the University expanded to Kenya, Tanzania, Uganda, United Kingdom and Afghanistan. AKU began life as a health-sciences university.
Clinical Trials Unit (CTU) is dedicated to develop a center of excellence for high quality and high impact clinical trials both nationally & internationally. The Unit 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.

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.

Aga Khan University invites applications for the regular full-time position of Senior Research Coordinator in Clinical Trials Unit.

Responsibilities:

The incumbent shall have responsibility of coordinating and managing multiple research programmes or a research unit of a department. Individual at this position should have exceptional understanding of research project management and skills to train juniors on research management as well as the ability to independently supervise and carry forward research projects.

You will be responsible for:

• independently organize and manage multiple studies.
• review clinical trials protocols for GCP and operational perspectives and share feedback with supervisor.
• support and facilitate the Principal Investigator in the development of clinical trial protocols.
• prepare and submit study documents to the ERC, NBC and DRAP for initial and ongoing review and approval.
• submit safety events and progress reports as per timelines.
• draft categorized study budget with justifications. Confirm accuracy and completeness of the cost.
• initiate and execute study agreements (clinical trial agreement, DTAs, MTAs CDAs and MOUs etc.).
• develop and execute recruitment plan for assigned studied.
• facilitate and train research team on protocol, CTU, institutional and other clinical trial SOPs and guidelines.
• counsel study participants about clinical trial and obtain written consent as required.
• manage subjects visit in CTU and ensure compliance to institutional policies and procedures.
• oversee IP dispensing, labelling, storage, and accountability.
• supervise and oversee the specimen management i.e., collection, storage, and shipment.
• maintain and update investigator site file/trial master file according to the sponsor and institutional requirements.
• supervise data collection, entry and storage and ensure compliance to ICH-GCP and other regulatory guidelines.
• maintain effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• coordinate with sponsors and CROs for trial meetings, draft meeting minutes and share with investigators and sponsors.
• work with the PIs to manage the day to day activities of the study including problem solving, communication and protocol management.
• facilitate monitoring and audits. Develop action plan and implement approved recommendations.
• track trial finances and timely notify PI and CTU any discrepancies.
• liaison with internal departments i.e., laboratory, radiology, HIMS etc. for services and support.
• submit accurate and timely closeout documents to ERC, NBC and DRAP and Research office.
• arrange secure storage of study documents that will be maintained according to the sponsor’s requirement or university policy whichever is longer.

Requirements:

You should have:

• Masters (MSc. Epi & Bio, MPH, MScN, or M.Ed., or equivalent) with 5 to 6 years research related experience

OR

• M.Phil with 3 to 4 years research experience current registration & be in good standing with your professional association.
• BLS and GCP certification with validity within 2 years (for clinical trials).
• good understanding of grant management processes and associated stakeholders at the University level.
• sound working knowledge & proficiency in human clinical trial processes, good clinical practices (GCP) & regulatory requirements.
• skills in teaching & training staff.
• good interpersonal & communication skills.
• multitasking ability and work under pressure.

Comprehensive employment reference checks will be conducted