Research Officer

Job Description

General Responsibilities 

• Maintain an up-to-date understanding of the applicable trial regulations, both local and international, train investigators on regulatory changes and ensure that these standards are  implemented in all research managed by the CTU.
• Contribute to the development of quality and efficiency within the CTU.
• Coordinate all regulatory, logistical, training and reporting tasks associated with running a clinical  study/trial.
• Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
• Be a part of a team that provides training for senior hospital/research staff on the ICH guidelines of Good Clinical Practice.
• Monitoring study activities.

Key duties/tasks:

• Understand relevant clinical research protocols and regulatory requirements.
• Develop standard operating procedures to control the quality of study conduct.
• Organize logistics of study materials including drugs, files, test kits, patient samples, data  and other materials in co-ordination with OUCRUNP administration and project managers.
• Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
• Train study staff and investigators in protocol relevant procedures including those for samples collections, data collection and recording, medication and patient assessment.
• Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files,  maintaining patient charts and supply inventories, etc.
• Verify that data entered on to the CRFs is complete and consistent with patient clinical notes, known as source data/document verification.
• Coordinate patient visit schedule as per study protocol.
• Supervise how the study is conducted to ensure compliance with the principles of Good  Clinical Practice, which will involve visiting the study sites on a regular basis.
•  Track study progress and identify problems. Report to stakeholders as required.
• Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
• Organize and participate in group meetings to share experience and contribute to the knowledge of others in the team.
• Develop CTU forms, review SOPs

Study Coordination

• Coordinate with study team members regarding study progress
• Conduct and coordinate study meeting
• Communicate with international teams, hospital sites, NHRC.
• Interaction with research staff regarding difficulties and possible solution to follow the protocol.
• Coordinate regarding deviation from the protocol from staff and submit needed protocol deviation, violation, SAE to concerned authority.
• Coordinate with study team and regulatory authorities regarding approvals and  amendments
• Data management

Monitoring: 

 Overall Monitoring of study conduct which includes

• Site assessment
• Training and delegation of responsibilities for staff
• Source data verification
• Ensuring updated documents are being used
• ICF is properly obtained and documented
• Protocol and SOPS are followed
• Investigational product accountability and dispensing, randomization process

Tasks specific to studies FIND and ACT 

• Study coordination, Monitoring, and data management of FIND. Monitoring of ACT.

Required Qualification & Experience

Essential Criteria: 

• Degree in Medicine, Pharmacy, Nursing, Science, Public Health or health sciences
• Strong diplomatic skills
• Proven oral and written presentation skills
• Excellent communication and interpersonal skills
• High level of organizational and record-keeping skills
• Excellent Nepali and English language skills

Desirable Criteria: 

• Experience conducting or managing clinical trials
• In depth understanding of ICH-GCP
• Work experience of a Health Research Institution

How to Apply

Note: The management of the organization has the right to have the above Job Description amended, increased, or changed as and when the need arises.

Eligible interested applicants are encouraged to apply for the above positions along with their resume and cover letter before July 29, 2022, 23:00 p.m. at oucrunp.hr@oucru.org. Only shortlisted candidates shall be contacted for further process.