29 days old
2018-06-152018-07-16

Manager, Institutional Review Board (IRB)

Weill Cornell Medical College
New York, NY
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Position Summary



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



Job Responsibilities



+ 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



Education



+ Bachelor's Degree



Experience



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\.

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Manager, Institutional Review Board (IRB)

Weill Cornell Medical College
New York, NY

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Manager, Institutional Review Board (IRB)

Weill Cornell Medical College
New York, NY
US

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