JOB SUMMARY:

The Lead – Clinical Trials Office line manages a team of Research Coordinators, promoting the team’s professional development, and ensuring that they act in compliance with study Protocol, Sidra Policies and Procedures, ICH-GCP guidelines and local MoPH Standard of Good Practice.

The post holder ensures that the Research Coordinators are trained and competent to perform all the activities relevant to the research studies they have been allocated to. S/he is responsible for the coordination of a portfolio of clinical studies within the Clinical Trial Office and works collaboratively with the Clinical Trials Office (CTO) Manager, maintaining strong relationships and positive communication with Principal Investigators (PIs), Co-Investigators, Research Nurses, Sponsors, and other relevant stakeholders as required, providing expert support for academic and industry research studies, driving study set up and delivery of projects and managing study close-out activities.

KEY ROLE ACCOUNTABILITIES:

• Effectively leads a team of Research Coordinators assigned to Clinical Research Projects.
• Serves as primary operational contact for the assigned Research Coordinators.
• Interacts closely with PIs and Research Coordinators.
• Assists with Sidra Internal Research Council (IRC) and Institutional Review Board (IRB) submissions, which includes guiding PIs through the local regulatory pathway, assisting in drafting Research Protocols, assessing study feasibility and risk scores, preparing essential documents including writing informed consent forms, designing CRFs, DSMB charts and other IRB study related essential documents.
• Assists Research Coordinators in maintaining study Master Files in an up-to-date and accurate manner.
• Assists with the amendment of existing Academic Protocols as required and with adapting local study documentation in response to protocol amendments.
• Assists the Research Coordinators in preparing for internal and external Monitoring Visits and Regulatory Audits.
• Assists Research Coordinators and Study team liaising with Industry Sponsors and Contract Research Organizations (CROs), as required.
• Leads effective communications and collaborations with industry Sponsors and CROs and their teams including Clinical Research Associates (CRAs), as required.
• Assists with managing study development tracking system and database and oversees the Research Coordinators updating details and timelines within the study tracking system.
• Collaborates with other study members (i.e. Research Nurses, Research Pharmacists, site Clinical Research Monitor) and any other relevant departments to ensure teamwork, support and research compliance.
• Manages the Toggle Software and intensity tool, for capturing Research Coordinators work activities and ensures that the team accurately reports the time spent on individual tasks in each study.
• Collaborates with the Research Operation team as required including providing Research Coordinators allocations quarterly reports to the Business Manager.
• Contributes to research induction and training of new staff, as required.
• Works collaboratively with the CTO Manager and CTO Research Nurses to develop and roll out workforce planning tools to ensure efficient utilization of staffing, taking the lead in implementing changes as needed.
• Provides training and updates to Research Coordinators, as required.
• Has a flexible attitude to work to reflect operational requirements.
• Assists with other projects, as needed.
• 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

QUALIFICATIONS & EXPERIENCE

Education:

Bachelor’s degree in biology, health/ biomedical sciences or equivalent

Experience:

7+ years of experience including 2+ years of progressive supervisory experience in Research Project Management and/or Research Coordination inclusive of:

• Prior experience in the management of Research Coordinators
• Experience with multi-national Research Projects
• Excellent knowledge of ICH-GCP standards and FDA/EU Research regulations
• General understanding of medical terminology and Clinical Trials concepts
• Excellent knowledge ICH-GCP standards, FDA/EU regulations and guidelines related to human subject research, including in relation to the conduct of Clinical Trials
• Knowledge of NDA/Clinical Trials Agreements (CTA), Clinical Trials costing