The Research branch will house several hundred researchers working on many aspects of Feto-maternal health. It will cover Basic, Translation, Clinical trials and Informatics research. The department comprises two research floors totaling 10,000M2 and 9 smaller “satellite laboratories” throughout the hospital. The department will house basic laboratories as well as state-of-the-art core facilities, e.g. Genomics, Medicinal Chemistry and Imaging.
This role reports to Office of the General Counsel.
The Manager - Clinical Research Governance is responsible for support of daily IRB operations and quality improvement initiatives including the review of existing IRB policies and procedures. Ensuring best support, excellent service. And that IRB and research complies with regulatory and ethical standards as well as institutional policies and procedures.
Works closely with investigators during the review and approval process and advises researchers on regulatory and ethical standards as well as institutional policies and procedures.
Serves as reviewer for initial submissions to the IRB that may be eligible for exemption or expedited review. This includes the review of submissions for completeness, eligibility for exempt or expedited level of review, and adherence to institutional policies, regulatory and ethical criteria for approval.
Conducts pre-reviews of requests for modification of previously approved research.
Provides consultation to the research community on submission requirements and acts as a resource to one or more other convened IRBs as required.
Manages the provision of training when required including community outreach and human subject research educations.
Responsible for critical results including:
Consistent, timely, thorough preparation of IRB materials and documentation
Tracking of conflicts of interest and the appointment/reappointment process of members of the IRB
Well developed, high trust, high performance work team
Quality customer service and consultancy to all colleagues, business partners and institutional organizations.
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.
Bachelor’s Degree in relevant field
5+ years’ experience in managing clinical trials on human subjects or similar health related projects in an IRB
Experience in budget management
Experience in developing, maintaining and producing information from databases
Knowledge of regulatory and governance requirements for clinical trials and those related to the IRB
Knowledge of trial methodologies, including clinical statistics and health economics
Demonstrated ability to use initiative and motivate others
Must be able to work independently with minimal supervision
Outstanding organizational skills and the ability to function in a team environment
Demonstrated substantial problem solving skills and excellent negotiating skills
Effective written and verbal communication skills
Proficient with IT tools including databases
Proficiency with Microsoft Office suite
Fluency in written and spoken English
Experience in facilitating clinical research
Certification as an IRB professional or ability to become certified within one year
Employer will assist with relocation costs.
Internal Number: SIDRA 4648
About Sidra Medicine
Sidra Medicine is a state of the art academic medical center that will function to the level of the highest international standards. Its clinical focus is on the specialty care of women and children.
Sidra’s Vision is: “Sidra Medicine will be a beacon of learning, discovery and exceptional care, ranked among the top medical centers in the world”.
Achieving this vision will encompass three essential activities:
World Class: Patient and Family Centered Care Health Education Biomedical Discovery
Once fully operational by mid-2018, Sidra Medicine will handle 275,000 outpatient appointments, 11,000 procedures, 100,000 emergency attendances and deliver over 9,000 babies per year, adding capacity to a rapidly growing population and delivering world-class specialist care.
The hospital will include 10 operating theatres, 400 beds, 100 percent single rooms with a private bathroom, a birthing center and an emergency department.