Officer - Clinical Trials Office

The Officer - Clinical Trials Office provides support to the Principal Investigator (PI) during the startup, conduct and close out phases of Investigators Initiated and Sponsored Clinical Trials within Sidra Medicine. 

Under the supervision and support of the Clinical Trials Office (CTO), as the Officer - Clinical Trials Office, the post holder is specifically responsible for the coordination and day to day management of a portfolio of clinical studies.

The post holder works collaboratively with PIs and nurses, providing expert coordination support in a clinical and academic research environment, driving study set up and delivery of projects. 

The post holder is primarily responsible for the coordination between the Investigators, and various stakeholders of the Research Projects and core facilities within Sidra, and with collaborating centers in Qatar and abroad. Specifically(s)he is responsible for setting up Regulatory Binders for Clinical Trials, liaising with the Pharmacy Department during the setup of interventional Clinical Trials facilitating research subjects’ recruitment, supporting with English/Arabic translation where needed, handling research sampling and completing related administrative tasks, collecting research data, recording information on research databases, uploading research forms and documents on IRBNet and monitoring the progress of the assigned Clinical Trials with the support of the CTO. 

The post holder is expected to collate and manage regulatory documentation to ensure the team is conducting research in accordance with ICH-GCP guidelines, Ministry of Public Health (MoPH) regulations and local Policies and Procedures. This varied and challenging post will involve among other tasks being committed to following up patients for the studies as required and is a key link for supporting patients and their families through ensuring that they receive appropriate and timely information regarding their inclusion and participation in the study. The post holder is instrumental in the patients’ retention in a study.

• Provides research coordination to Sponsored and Investigator’s initiated Clinical Trials which involve liaising with multiple stakeholders and core facilities and with external organizations.
• Practices in compliance with the IRB-approved Protocol, ICH-GCP and MoPH guidelines and Local Policies and Procedures.
• Organizes and maintains research databases/Regulatory Binders and files including patient information’s such as secured data and unidentified data, as relevant.
• Designs and manages the Case Report Forms (CRF), according to the different Clinical Trials.
• Coordinates and attends Site Initiation Visits (SIVs).
• Coordinates recruitment of patients and works closely with Investigators when they collect informed consents.
• Coordinates samples collection and transportation.
• Monitors recruitment and other metrics on a regular basis and liaises with the Project Management Office (PMO).
• Provides updates and reports of study data as needed to the CTO, for meetings and presentations.
• Supports PIs regarding submissions of protocol amendments for IRB approval.
• Adapts local study documentation in response to protocol amendments.
• Prepares for, and facilitates, audits and/or inspections.
• Works closely with the Pharmacy Department to ensure timely delivery of investigational Products (IP) to patients, monitors and records drug compliance in research patients and delivers patients’ drug returns to the Clinical Trials Pharmacy team.
• Reports promptly to the PI and the CTO, events which could result or have resulted in protocol violation.
• Organizes and supports monitoring visits.
• Coordinates patients’ follow up visits.
• Provides training, guidance and supervision to junior staff within the team where required.
• Contributes to research induction and training of new staff as required.
• Adheres to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies
• Adheres to and promotes Sidra’s Values.

In view of the evolving needs and opportunities within Sidra, this position may be required to perform other duties as assigned and reporting relationships may vary.