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.