Ethics and Pharmacy Officer

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. 

OUCRU Nepal’s mission is to have a local, regional and global impact on health by leading a locally driven research programme on infectious diseases.

Please see more information on OUCRU website: www.oucru.org

The Research Ethics and Pharmacy Officer will support ethical oversight for all research studies requiring ethical approval at OUCRU Nepal and support pharmaceutical management for clinical trials. The role ensures compliance with applicable regulations, supports investigators through ethics and regulatory processes, contributes to investigational medicinal product (IMP) management, and assists in strengthening pharmacy systems and ethical governance within the CTU.

Key Responsibilities

1. Ethics and Regulatory Compliance (All Research Studies)

• Ensure all research studies (including clinical trials, observational studies, and other human subject research) comply with local, national, and international ethical and regulatory requirements. 
• Coordinate with ethics committees/IRBs to obtain and maintain approvals for all studies. 
• Support investigators in preparation, submission, and follow-up of ethics and regulatory applications.  
• Maintain up-to-date knowledge of evolving ethical and regulatory frameworks. 
• Standardize workflows for protocol submission, review, approval, and renewals 
• Maintain a tracking system for all studies under the CTU
• Perform pre-submission ethical screening of protocols 
• Ensure quality and completeness of submissions (protocol, ICF, tools, etc.) 
• Manage applications for amendments, continuing reviews and SAE reporting

2. Stakeholder Engagement and Communication

• Manage communication and documentation related to ethics and regulatory submissions.
• Act as a focal point for ethics-related communication with OXTREC, NHRC, and other IRBs on behalf of OUCRU Nepal.

3. Material Transfer Agreements (MTA)

• Coordinate and manage MTAs between OUCRU Nepal, Oxford University, and external collaborators. 
• Prepare and review documentation to ensure compliance with policies on material transfer and confidentiality. 

4. Study Team Collaboration

• Work closely with Principal Investigators, research coordinators, and study teams. 
• Assist during monitoring visits and audits, including preparation of pharmacy and ethics documentation. 

5. Training and Capacity Building

• Provide training and support to staff on research ethics and regulatory requirements across all study types. 
• Contribute to strengthening ethics and pharmacy practices within the CTU. 
• Contribute to the development of Studyline for research project and portfolio management. 

8. Documentation and Quality Assurance

• Maintain accurate, complete, and audit-ready documentation for ethics and pharmacy activities. 
• Support development and revision of SOPs, templates, and logs. 
• Ensure readiness for audits, inspections, and monitoring visits related to pharmacy and ethics activities.

10. Pharmacy and IMP Support

• Support investigational medicinal product (IMP) activities, including procurement, receipt, storage, dispensing, and accountability in line with study protocols. 
• Support maintenance of appropriate storage conditions, including temperature monitoring and documentation. 
• Maintain accurate IMP documentation, including drug accountability logs and pharmacy records. 
• Support IMP inventory management, including ordering, reconciliation, returns, and disposal. 
• Coordinate with regulatory authorities for IMP-related approvals, licensing, and import/export requirements. 
• Ensure pharmacy documentation is complete and compliant for regulatory submissions. 
• Support compliance with GCP, GMP, SOPs, and applicable national regulations. 
• Assist during monitoring visits and audits related to pharmacy and IMP activities. 
• Support development and strengthening of the CTU pharmacy function, including systems, processes, and documentation. 
• Contribute to planning for pharmacy infrastructure and services. 
• Participate in development of pharmacy-related grants and concept notes.

Qualifications and Experience

• Master’s degree in Science, Pharmacology
• Experience in pharmacy related research preferred. 
• Understanding of research ethics frameworks, GCP, and regulatory requirements. 

Skills and Competencies

• Strong organizational and documentation skills 
• Attention to detail and compliance orientation 
• Effective communication

Eligible and interested candidates are encouraged to submit their updated CV to Job Application Form by the deadline indicated above. Only shortlisted candidates will be contacted for the next stage of the recruitment process.