Under the supervision of the Research Compliance Director, the IRB Manager conducts in-depth protocol review using advanced regulatory knowledge and experience.
S / he has primary responsibility to manage the protocol review process, identify issues and independently determine whether the components of the proposed research are in compliance with federal, local regulations and WCMQ policies.
Other duties include serving as an expert liaison between the research investigator and the reviewer; educating parties on relevant and emerging regulations, and identifying related risk management issues
Maintain IRB study related documentations in accordance with WCMQ policies, IRB policies, Federal & Qatari regulations
Manage and document all IRB activities. Supervise closely the operation of protocols review to meet the regulatory requirements and the relevant standards
Conduct preliminary review of submissions to the IRB, communicate deficiencies to investigators and ensure that the identified deficiencies are addressed adequately prior to review
Analyze and apply relevant regulations, policies and SOPs to ensure meeting the regulatory requirements in reviewing research protocols.
Draft and / or edit correspondence that conveys IRB determinations and contingencies for approval of research. Liaise between the IRB and the investigators.
Manage and supervise the daily operation of IRB coordinators. Delegate tasks as appropriate and evaluate the performance of coordinators regularly
Provide training and orientation to IRB coordinators and the research community
Oversee the preparation for IRB meetings; identify expertise required for appropriate review; work with coordinators to develop meeting agendas and ensure that study packets are assembled and distributed to IRB members.
Attend all IRB meetings to advise on applicable regulations & institutional policies. Ensure meeting the regulatory requirements for the conduct of committee review.
Review & edit IRB meeting minutes to meet regulatory requirements and IRB policies
Prior management and supervisory experience demonstrating the ability to train, guide and evaluate the performance of other support staff
Knowledge, Skills and Abilities
Demonstrated proficiency in written and spoken English language (including medical terminology) is required.
Excellent organizational skills and strict attention to details.
Proficiency in both Arabic and English is preferred
Must be comfortable in multi-tasking and have demonstrated independent analytical and problem solving abilities
Comprehensive knowledge of Federal regulations, ICH-GCP guidelines and ethical principles regarding human subjects in research
Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management
In-depth understanding of operational requirements pertaining to management and implementation of protocol process
Licenses and Certifications
CIP certification required.
Working Conditions / Physical Demands
Work typically takes place in a normal office environment and requires : standing, walking, sitting, operating a PC and other office equipment
Weill Cornell Medical College in Qatar was established in 2001 as a partnership between Cornell University and Qatar
Foundation. The first medical school in Qatar and a pioneer of coeducation at university level, WCM-Q offers an integrated program of pre-
medical and medical studies leading to the Cornell University M.D. degree. Teaching is by Cornell and Weill Cornell faculty, including physicians at Hamad Medical Corporation (HMC) who hold Weill Cornell appointments.
Enrollment has grown rapidly from 25 first year pre-medical students in fall 2002 to over 200 students from more than 30 countries as we entered our sixth year of operation in September 2007.
WCM-Q is part of Weill Cornell Medical College, which was founded in New York City over 100 years ago, and shares the same mission :
to provide the finest education possible for medical students
to conduct research at the cutting edge of knowledge
to improve health care both now and for future generations
to provide the highest quality of care to the community
Weill Cornell Medicine-Qatar is an Equal Employment Opportunity / Minorities / Females / Vet / Disabled employer.