Reports to: Director
Contract: 100%, 1 year with the possibility of an extension
Salary: As per organization policy
Start date: As soon as possible

Summary of Role:

• To coordinate studies and manage all aspects of research governance and support for OUCRU NP research.

Background: 

OUCRU-NP was founded in 2003 and has since established a reputation as one of the leading clinical research groups in Nepal. There has been considerable investment in upgrading the laboratories and in training young Nepalese clinicians and scientists. The main research focus is on the most common infectious diseases affecting the Nepalese population with a major focus on undifferentiated febrile illnesses and antimicrobial resistance.

Responsibilities and tasks of post holder:

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified clinical research support staff to ensure efficient and high-quality research operations in line with international standards. The post of Clinical trial Unit Manager will be expected to:

• Coordinate studies and support principal investigators on day to day study management
• Contribute to the continued growth and development of the CTU team
• Build research capacity at institutions
• Manage all aspects of research governance and support for OUCRU NP research

A. Management/Leadership

• Together with the PIs and OUCRU NP leadership, contribute to the decision-making process for how clinical trials re managed.
• Ensure OUCRU-NP research studies are performed to a high standard by providing optimal staffing and collaborating with the clinical and non-clinical support services departments.
• Develop, coordinate and implement systems and procedures to standardize research documentation and management across all OUCRU research 
• Ensure and maintain consistency with OUCRU programme-wide procedures regarding study operations and governance by frequent liaising with OUCRU-VN.
• Perform assessments and evaluations to determine needs and best approaches to implementation of new processes, protocols, and procedures.
• Establish “trial site files” in accordance with “international conference on harmonization (ICH)”, good clinical practice (GCP) and research Governance.
• Co-develop data and operational tools to deliver research studies including protocol specific Case Report Forms, Standard Operating Procedures, Data Management Plan, DSMB Charter, Informed Consent Forms, Monitoring Plan, Regulatory documentation and training.
• Support Principal Investigators in the development of research protocols consistent with the guidelines of Good Clinical Practice and local regulatory/operational requirements.

B. Governance (Ethics and regulatory, Monitoring):

• Assist international collaborators with remote monitoring and dissemination of the report through debrief meeting.
• Maintain an up-to-date understanding of the applicable trial regulations, both local and international, across OUCRU-NP Unit and train investigators on regulatory changes to ensure that standards are implemented in all research managed by the unit.
• Implement and maintain Unit’s policies related to the set up and conduct of clinical trials. Advise within the Unit and all collaborators on all matters relating to operational support of ongoing clinical trials including regulations, management, monitoring, data management, ethics, etc.
• Support development of project agreements and other research related contracts and contribute to solve all issues related to study budgets and payments.
• Act as focal point in liaison with regulators, ethical committees and CTU OUCRU-HCMC to ensure optimal communications between OUCRU-NP and these bodies.
• Approach Patan Hospital executive committee, different hospital departments and ethics committee (hospital IRBs, NHRC, OxTREC) for study set up and approvals and amendments.
• Manage the resources of the CTU Monitoring Team and advice on strategy implemented to provide optimal oversight of research quality across all OUCRU studies.

C. CTU Operations (Data, Pharmacy, operation) and study specific coordination

• Build relationships and maintain good and frequent communication with collaborating staff at study sites, to ensure participants’ well-being, compliance with study protocols and quality of clinical data.
• Together with the CTU team, ensure proper planning, implementation, coordination and supervision of all study procedures for assigned projects as per protocol, hospital policies, OUCRU policies and GCP guidelines. This will involve frequent visits to the study sites.
• Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
• Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and research related patient procedures.
• Co-ordinate the study meeting, trial management group meetings, trials steering meetings and the data safety and monitoring board meetings.