| Human Research Protection Specialist -- Boston, MA |
Author: Jon Merz
Date: 06-21-10 17:58
COMPANY: Harvard Pilgrim Health Care, Office of Sponsored Programs
JOB TITLE: Human Research Protection Specialist
LOCATION: Boston, MA
SUMMARY OF POSITION
The Human Research Protection Specialist is responsible for the day to day operations of the Institutional Review Board to facilitate the review and approval process and ensure institutional compliance with federal and state laws, regulations, institutional policies and guidelines governing human research protection. S/he s erves as the principal interface between the HPHC Human Studies Committee (HSC) and internal and external researchers. Co nducts quality assurance audits to insure regulatory compliance; develops and implements training for investigators, IRB members and staff; maintains HPHC’s IRBNet and CITI programs.
JOB FUNCTIONS
1. Reviews applications for Human Studies research approval submitted by grants managers. Consults with grants managers and investigators regarding best practices and may recommend revisions to research protocol submissions. Responds to questions on preparing and submitting applications and reviewing policies and procedures. Reviews accompanying documentation for consistency with stated protocol.
2. Reviews emergency requests, amendments and revisions for completeness and compliance with committee standards prior to convened Institutional Review Board (IRB) review.
3. Makes determination as to whether an application needs to be reviewed by the full IRB committee or can be expedited to a subset of the committee.
4. Prepares IRB meeting agendas and member review materials. Assigns each application to a primary and secondary reviewer from the IRB. Attends committee meetings.
5. Prepares decisions reports from IRB meetings of required actions and final approval notices and associated documentation; communicates IRB decisions to investigators and grant managers.
6. Tracks all IRB-related documents from time of submission to time of study termination; maintains database for tracking research projects and affiliated IRB documents. Prepare tickler report and prepare and email reminders and forms.
7. Conducts audits of IRB approved research for compliance with federal regulations and HPHC/I policies. Determines if corrective action is needed, and if so, works with investigators to make corrections. Communicates findings to investigators, grant managers, and IRB.
8. Develops educational programs and guidance documents for investigators and IRB members about human research protection and compliance issues. Maintains CITI program training materials and determines which modules are appropriate for HPHCI.
9. Reviews changes in Human Studies regulations and insures they are incorporated into training programs.
10. Assists in developing, recommending and implementing policies and procedures to enhance efficiency of committee operations.
11. Maintains and continually refines computerized databases to allow for timely tracking of research.
12. Oversees maintenance of IRB records and files, paper and computer based.
13. Conducts other human research protection responsibilities as needed in order to address compliance issues.
14. Provides positive and effective customer service that supports departmental operation.
15. Maintains positive relationships with co-workers and departments.
16. Coordinating with members of the Office for Sponsored Programs (OSP) on all other aspects of the review of research proposals and awards.
MINIMUM REQUIREMENTS
Education: BA/BS degree preferred or equivalent work experience.
Experience: 3 years experience within a resarch setting with strong preference for prior experience in human research protection, research procedures and/or institutional review board operations.
Preferred Skills/Qualifications:Excellent organizational and interpersonal skills; Ability to understand and apply complex human subject research issues; Ability to work independently and perform against deadlines with competing priorities; Ability to exercise sound judgment and initiative in collecting technical information from a variety of sources; Excellent oral and written communication, problem solving and analytical skills required; Ability to maintain strict standards of confidentiality in dealing with protected information; Certification as IRB Professional (CIP) highly desired.
Skills/ Competencies: Demonstrated experience with Microsoft Word, Excel and Power Point
ORGANIZATIONAL RELATIONSHIPS/SCOPE
Reports to Institutional Review Board Administrator; frequent contacts include members of the IRB, grants managers, investigators and other research staff.
WORKING CONDITIONS
Normal office conditions; must have the ability to commute between HPHC/I locations as required by the position.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Harvard Pilgrim is an equal opportunity employer and does not discriminate in employment on the basis of race, religion, gender, gender identity, genetic information, age, sexual orientation, national origin, or veteran or disability status. Harvard Pilgrim complies with all applicable laws concerning hiring and employment practices.
TO APPLY, please copy/past the link below:
https://www.harvardpilgrim.org/portal/page?_pageid=213,271911&_dad=portal&_schema=PORTAL .
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Author |
Date |
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Human Research Protection Specialist -- Boston, MA |
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Jon Merz |
06-21-10 17:58 |
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