| Manager of IRB Operations and Systems -- Belmont, MA |
Author: Jon Merz
Date: 08-19-11 04:26
Company Name: McLean Hospital
Position Title: Manager of IRB Operations and Systems
Min Education: Master's Degree
Location(s): Belmont, Massachusetts, United States, 02478
Apply URL: http://www.Click2Apply.net/988rf8p
Industry: Healthcare / Health Services
Job Function: Executive/Management
Min Experience: 5-7 Years
The job description is as follows:
Manager of IRB Operations and Systems
Mclean Hospital, Belmont, MA
About Our Organization
As a leader in psychiatric care, education and research, McLean Hospital stands on a firm foundation of excellence built and maintained by its employees. With more than 1,700 staff, McLean has created a close-knit community in a caring work environment that promotes professionalism and pride. Within this supportive environment, our employees have the opportunity to learn, grow and contribute to McLean's 190-year mission of providing a broad spectrum of the highest quality care, fostering research on new prevention and treatment methods and training new generations of clinicians and investigators. Thanks to our employees, McLean is consistently ranked the nation's top psychiatric hospitals by U.S. News & World Report.
General Description
Under the general direction of the Director of the Human Research Ethics Program, the incumbent has overall responsibility for the operations of the IRB, including development of systems to support the IRB review process. Directly reports to the Director of the Human Research Ethics Program.
Principal Duties and Responsibilities
* 1. Develop and implement forms, tools and procedures for submission of protocols and related documents for IRB review to assure compliance with institutional policies and procedures and state and federal regulations governing protection of human subjects. Serve as operational liaison to research community.
* 2. Develop and implement standard operating procedures for IRB review activities to assure compliance with institutional policies and procedures and state and federal regulations governing protection of human subjects.
* 3. Develop and implement performance standards. Measure performance and identify and implement solutions to IRB process or systems problems. Work closely with Partners IT and McLean Research Administration.
* 4. Participate in the development and implementation of human subject protection and IRB review policies and procedures.
* 5. Develop Educational programs for PIs and research staff regarding HRPP and regulatory issues.
* 6. Provide regulatory guidance to investigators and research community.
* 7. Conduct training sessions as appropriate for research staff.
* 8. Orient new IRB members.
* 9. Coordinate IRB authorization agreements.
* 10. Investigate and respond to complaints from the research community regarding IRB operations.
* 11. Participate in IRB quality improvement activities.
* 12. Act as primary IRB liaison to ancillary committees related to coordination of IRB review activities and hospital departments related to communication about IRB approval.
* 13. Serve as Executive Secretary/Administrative Chair of McLean IRBs.
* 14. Serve on the McLean Compliance Committee as the representative of the McLean IRB.
* 15. Interact with the Office of the General Counsel, Research Administration, Partners Office of HRPP, as needed, on issues related to IRB review and/or human subject protection.
* 16. Interact with representatives from regulatory agencies, such as OHRP, FDA, and DPH, as needed.
Skills/Abilities/Competencies Required
* Extensive knowledge of human subject protection regulations.
* Excellent oral and written communication skills.
* Excellent organizational skills.
* Excellent interpersonal skills.
Qualifications
* Minimum 6 years of IRB Experience
* Current certification as an IRB manager (CIM) or IRB professional (CIP)
* Master's degree in a related field
Working Conditions
Standard office environment
Supervisory Responsibility
Supervise 2 IRB Staff Professionals
Fiscal Responsibility
Oversee IRB Budget reporting to both the Director of the Human Research Ethics Program and the Executive Vice President / Chief Operating Officer.
Conditions of Employment
Employment at McLean Hospital is contingent upon a successful CORI (Criminal Background Check), National Background Check and clearance from the Occupational Health Department.
EOE Statement
As an equal opportunity employer, McLean seeks qualified candidates for all posted employment opportunities without regard of race, color, age, religion, gender, national origin, disability or veteran status.
Please apply online at www.mclean.harvard.edu.
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