| Director, Human Research Protection Program -- Danville, PA |
Author: Cathy Betz
Date: 07-18-11 21:48
GEISINGER HEALTH SYSTEM - Director, HRPP
JOB SUMMARY:
Having an effective, supportive, flexible and yet compliant human research protection program is fundamental to Geisinger’s success at building its research enterprise and in achieving the goals of the research strategic plan. A complicated human research protection program with over 600 active protocols, internal and external IRBs, the availability of EHR and GHP data sources, the extensive QI and innovation projects, innovative tissue and data broker arrangements, and changing ratios of exempt and non exempt research, the mix of research presents challenges not found at most institutions.
This leadership position is responsible for guiding and ensuring the Geisinger Health System’s compliance with international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research, the use of PHI in research activities (HIPAA), and ensuring that research at Geisinger involving human subjects is conducted in a manner which protects the safety, rights, and welfare of all subjects. To accomplish these mutually reinforcing goals, the Director works with the Institutional Official (the Chief Scientific Officer), Chief Administrative Officer for Research, the Chairs of the Institutional Review Board (IRB), the Director of Research Compliance, Legal Services, Internal Audit, Privacy and others to coordinate and manage a comprehensive program for the protection of human subjects in research (HRPP). To do this, the Director is responsible for establishing, maintaining, and continually improving the policies, systems and procedures for review, approval and continuing oversight of the use of human subjects or their PHI by researchers affiliated with Geisinger through the Geisinger IRBs (GIRB), facilitated review processes, or through contracted IRBs. The ability to effectively train and develop the capabilities of IRB chairs and members, as well as training the general Geisinger community is a key factor in the success of the position, as is the ability to translate and communicate to the research community the subtle nuances of the regulations and the way they are applied to different types of research.
Reports to the Chief Administrative Officer for Research.
MAJOR DUTIES AND RESPONSIBILITIES:
*1. Manages federal wide assurance, IRB registration, and inter-institutional agreements for IRB reliance to allow for engagement in federally-conducted or –supported human subjects research activities, including:
a. Submission of federal wide assurance, changes to IRB rosters
b. Determines need for, negotiates and prepares inter-institutional agreements for cooperative research.
c. Responsible for proposing arrangements for reliance on other IRBs, including the NCI-supported Central IRB (C-IRB), developing methods for facilitated review, and continuing oversight of protocols reviewed and approved by IRBs other than GIRB.
d. Maintains registration with federal agencies, providing annual or more frequent reports, as required to maintain institutional status.
*2. Develops and maintains human research protection program of the highest quality to foster excellent research and assure regulatory compliance. To accomplish these tasks, undertakes the following types of non-inclusive activities:
a. Develops and implements policies and procedures sufficient to ensure adequate regulatory compliance oversight for both GIRB protocols as well as those projects overseen by other IRBs.
b. Interprets and applies relevant federal and state laws, regulations, institutional policies and guidelines in resolving issues related to protocol review. Uses available resources and independent judgment in interpreting and applying relevant federal and state laws, regulations, institutional policies and guidelines in resolving issues related to protocol review.
c. Oversees relationships with external IRBs.
d. Takes a lead role on preparing for and sustaining accreditation by AAHRPP.
e. Coordinates HRPP activities with those of the Office of Sponsored Projects, IBC, Radiation Safety, Pharmacy, Environmental Safety, etc. with other regulatory committees, and appropriate offices.
f. Serves on Health System committees and participates in Geisinger Health System initiatives of relevance to use of humans in research.
g. Develops and maintains contacts among peers at other institutions. Monitors on-going national discussions on regulatory and ethical issues.
h. Maintains current and historical files to meet federal/state/local requirements for all protocols.
i. Continuously strives to streamline procedures and reduce the burden of compliance on investigators, while maintaining compliance, upholding ethical principles and ensuring accountability.
j. Responds to inquiries from both within and outside the Geisinger Health System and from investigators, staff and administrators regarding the HRPP policies/procedures, metrics, training, etc.
k. Identifies the need for and develops communications with investigators and administrators regarding the impact of proposed, current, and upcoming regulations, GIRB policies and procedures.
l. Maintains membership and participation in appropriate organizations for research compliance.
m. Interprets current and new federal/state regulations, advising the Chairs, committee members, analysts and others regarding implementation, guiding the development of HRPP policies, announcements, standard operating procedures, etc. to implement these regulations.
n. Represents Geisinger in audits and deliberations with federal, state and local agencies and organizations, as well as with sponsors.
o. Effectively communicates and trains all relevant individuals (including, but not limited to, newsletters, presentations, training programs, introductions to the HRPP, GIRB Member training, GIRB policy and procedures, Website).
p. Responsible for approval of expeditable amendments (admin types), exempt status and research determinations
q. Conducts investigations of incidents of non-compliance for Geisinger protocols, regardless of which IRB served as IRB of record.
r. Collaborates with the Office of Research Compliance, Legal, Privacy, Internal Audit and others in investigations involving entities beyond the IRB
*3. Ensures Geisinger IRB (GIRB) Committee compliance, oversight, and committee operations.
a. Ensures the GIRB’s compliance with 45 CFR 46 and other pertinent regulations
b. Ensures Geisinger Health System's compliance with HIPAA regulations on research and GIRB's role as Privacy Board for the institution.
c. Ensures proper membership of the GIRB, identifies the need to recruit new members and prepares appropriate recruitment and training materials.
d. Supervises the review cycle of protocols, including committee meetings and resulting approvals and requests for modifications to protocols.
e. Develops and revises GIRB forms as necessary to capture needed information.
f. Implements policies and practices for protocol intake, processing, review and approval and on-going oversight.
g. Establishes policies and practices for committee meeting management and administration, including setting agenda, developing meeting minutes, analyzing investigator responses, ensuring complete and auditable electronic and paper records.
h. Supports respective Committee chairs and vice chairs.
i. Ensures complete protocol history is entered from submission of new applications and all subsequent protocol events information in the database.
j. Develops and implements programs providing education and training to all levels of research staff in the conduct of research involving human subjects.
k. Develops and implements training programs for GIRB members and staff.
l. Establishes qualitative and quantitative metrics for committee operations.
*4. Directs the Human Research Protection Program Office.
The HRPP Director directs all aspects of HRPP office, providing management and support for staff
to promote the professional development and the long-term commitment of employees.
a. In managing the staff, the HRPP Director is responsible for:
•composing job descriptions and for establishing the requirements for the HRPP and IRB Staff
•conducting performance evaluations following the policies of the Geisinger Health System Human Resources Department
•developing performance standards and job expectations and making modifications as necessary
•recruiting, hiring, and termination of HRPP and IRB Staff.
•training of HRPP and IRB staff and establishing work priorities and deadlines.
b. In regards to the overall management of the office, the HRPP Director:
•periodically evaluates resources and staff, taking into consideration the volume of items administered by the staff; complexity and types of human research activities administered by the staff; the time staff has to devote to the activities and quality of the activity outcome
•evaluates work and provides metric reports based on agreed service levels on a regular basis. Makes process changes to ensure that the entire administrative process is accomplished in a timely manner
•assesses whether additional staff, equipment, finances, education, and space are needed to protect the rights and welfare of research participants. The HRPP Director reports the results of the evaluation to the Chief Administrative Officer, Research.
•works collaboratively with investigators, senior management, committee chairs and staff to establish administrative service expectations.
•Determines need for and leads implementation of computer and web-based applications to continually improve and simplify the processes of protocol submission, continuing review of active protocols and reporting of adverse events and protocol violations.
•manages HRPP office budget
•establishes protocol review costs for industry studies reviewed by GIRB, and works with Research Finance to ensure invoicing and payment reconciliation for GIRB review is done in a timely manner.
5. Performs other duties as required or assigned.
*Denotes essential job functions.
SKILLS AND ABILITIES:
Demonstrated proficiency with the regulatory guidelines for human subject participation in research and ability to apply these complex regulations and policies to diverse types of research.
Demonstrates excellent verbal and written communication skills and ability to interact with researchers and other employees in a positive and confident manner.
Demonstrates excellent organizational skills necessary to establish priorities and meet deadlines while attending to details.
Demonstrates well developed supervisory and leadership skills.
Demonstrates ability to maintain professional standards of conduct under severe time constraints.
Demonstrates ability to work independently and cooperatively and to function successfully under time pressures.
Demonstrates ability to maintain confidentiality of information and records.
Demonstrates excellent interpersonal skills to effectively interact with diverse clients.
EDUCATION AND/OR EXPERIENCE:
Bachelor of Arts or Science degree required. Master's or advanced degree preferred.
Minimum ten years senior administrative experience in regulatory compliance and research with human subjects required.
Expert knowledge of regulatory and agency requirements for the ethical conduct of research with human subjects and quality assurance programs routinely required by the Department of Health and Human Services (OHRP, Food and Drug Administration, including Good Clinical Practice. National Institutes of Health, Office of Civil Rights) required. Familiarity with other relevant regulations for the use of biological agents, radiation, animals, conflicts of interest, misconduct, and other relevant principles,
Experience conducting clinical research or working in institutions with a range of research types, including clinical trials, clinical research, epidemiology and other types of social sciences research.
Significant supervisory experience required.
CIP certification preferred (may be substituted for some of the requirements above).
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work is typically performed in an office environment.
The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.
Interested candidates, please contact Shawna Seger, Senior Administrative Assistant at 570-214-5329 or smseger@geisinger.edu.
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