Author: Jon Merz
Date: 05-24-10 14:08
Director Research Compliance/Qatar-12627
Description
POSITION SUMMARY
Under guidance of the Associate Dean for Research, directs the Research Subjects Protection Program of WCMC-Q. This includes coordinating and liaising with the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Bio-safety Committee (IBC), Data Safety Monitoring Boards (DSMB) and the research component of the Health Insurance Portability and Accountability Act (HIPAA); ensuring compliance with U.S. Federal, NY State and Qatar regulations governing human and animal subject research; educating faculty and research staff on the regulatory and ethical issues involved in conducting human and animal subject research, and advising faculty and research staff on the use of humans and animals in research. Also, provides administrative support and training for the Hamad Medical Corporation (HMC) Human subjects compliance program and IRB.
MAJOR RESPONSIBILITIES
1. Coordinates all regulatory committee activities for the medical college to include the design and implementation of all institutional committee functions. Responsible for interpreting institutional and federal policies, procedures and regulations. Communicates on a technical level with faculty regarding conduct of research as applied to ethical considerations. Oversees the audits of IRB approved research protocols. Overseas the function of the weekly adverse events committee (subcommittee of the IRB (Institutional Review adverse events committee (subcommittee of the IRB (Institutional Review Board)). Provides the same administrative oversight for the HMC IRB.
2. Assists in the design, delivery and oversight of an education program for faculty conducting research involving human and animal subjects. Provides continuing education and professional development for the relevant boards and committees. Provides guidance on policy and review requirements to research investigators. Supervises interactions between the committees regarding preparation of protocols for review by the committees.
3. Prepares, submits and participates in the negotiations of the Assurance Documents along with periodic updates and the required annual reports. Along with the Associate Dean and Committee Chairs, represents the institution during site visits and audits by Federal regulatory agencies.
4. Coordinates with Grants and Contract administrators on research projects involving other university and research organizations to ensure issuance of required documents including but not limited to single Project Assurances and Cooperative Amendments. Prepares institutional certifications for grants submitted to organizations that provide grants including U.S. and Qatar Government agencies.
5. Advises professional scientists and physicians regarding the state and institutional regulations governing the use of human and animal subjects in research and conduct of industry sponsored clinical trails. Serves as liaison among faculty, staff, department administrators, committee members, veterinary staff, auditors and sponsors regarding medical college assurance policy and procedures.
6. Evaluates committee member performance and recommends replacements as required; prepares and reviews committee agenda, actions and policies with Chairs; ensures committeesŐ adherence to federal, state and institutional policies and regulations. Supervises staff; interviews prospective employees, recommends compensation for new hires, annual merit increases and conducts performance appraisals for personnel. Designs, develops and implements office operations and policy ensuring efficient workflow, office communications, assessments and effective prioritization of assignments. Provides appropriate training for staff to ensure effective support for committees and investigators.
7. Evaluates each human subject research study conducted at WCMC-Q for compliance with HIPAA, including reviewing drafts of authorization forms and data collection procedures ensuring compliance with Federal and state regulations governing the use of human subjects in research.
8. Overseas the record-keeping and file maintenance of confidential research files in the IRB, IACUC, IBC, DSMB and HIPAA office to meet audit standards. Maintains files on current state guidelines.
9. Administers an audit program for HIPAA which includes, devising a randomized and for-cause review process for non-compliance; checks stated purposes for data use in HIPAA authorizations against actual procedures; detects and mitigates against potential violations of HIPAA compliance as appropriate to patient information derived from Qatar services.
10. Supervises the IRB/IACUC committees and provides administrative support for HMC IRB, in establishing and administering educational programs and seminars regarding the rules and regulations applicable to the conduct of research involving human and animal subjects. Oversees the development and administration of new and existing courses, including the comprehensive IRB, HIPAA, and IACUC training. Monitors federal, state and other applicable regulations with reference to additional; education and training requirements related to human and animal subject research.
Qualifications
MINIMUM REQUIREMENTS
BA/BS, or the equivalent combination of education and experience. Previously demonstrated advanced level understanding of operational requirements related to the management and implementation of an IRB, IACUC, IBC, and DSMB. Previously demonstrated advanced level. Knowledgeable of U.S. Federal and NY State regulations, including HIPAA, governing the use of human subjects in research. Previously demonstrated advanced level. Organizational, interpersonal and communication skills. Previously demonstrated advanced level. Independent decision-making ability. Previously demonstrated advanced level. Experience people management skills. Prior experience working in a cross-cultural environment
* PREFERRED REQUIREMENTS
* BA/MS/MBA or other advanced degree
* Read, write and speak Arabic
* PHYSICAL REQUIREMENTS
* Work is completed in office environment.
* Approximately 60% is computer based, 40% lab based.
* The job requires extended and varying work hours to meet demands.
*
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, WCMC-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.
WCMC-Q is part of Weill Cornell Medical College, which was founded in New York City over 100 years ago, and shares the same mission:
ˇ to provide the finest education possible for medical students
ˇ to conduct research at the cutting edge of knowledge
ˇ to improve health care both now and for future generations
ˇ to provide the highest quality of care to the community
For more information please visit http://qatar-weill.cornell.edu/
Please send your Curriculum Vitae to:
https://cornellu.taleo.net/careersection/2001/jobsearch.ftl .
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