Job Board

https://www.joinwellspan.org/jobs/Institutional_Review_Board_Specialist/York_Pennsylvania/103/287510/
Job Description:

Under the general supervision of the Director, Human Research Protection Program (HRPP), provides technical and administrative support for the WellSpan Health (WSH) Institutional Review Board (IRB), investigators and research support staff. Assists in ensuring that the health system's clinical research activities are conducted in compliance with institutional SOPs and international, federal, state, and local laws and regulations and ethical principles regarding the use of human subjects in research. Ensures that research activities involving human subjects or their personal information are conducted in a manner that protects the safety, rights, and welfare of participants.

 Duties and Responsibilities

 

1. Maintain a current understanding and knowledge of federal and state regulations, state and local law, and WSH IRB SOPs.
2. Interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies for discussion with the Board and/or Board Chair.
3. Responsible for the ensuring timely processing, pre-review and disposition of assigned protocols, modifications, continuing reviews, unanticipated problems involving risks to subjects or others, and investigator responses.
4. Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs.
5. Prepare agenda and minutes for committee meetings in accordance with SOPs.
6. Work closely with, and in support of, the respective IRB Chair, Vice Chair, reviewers and other members.
7. Participate in all relevant institutional research educational activities related to human subject protections and IRB operations.
8. Maintain and ensure retention of all required IRB records, communications, and other documents.
9. Assist in the coordination of IRB activities with other WSH Service Lines and Departments.
10. Provide education and training on use of IRB electronic management system and other research-related programs with the research community.
11. Timely communication with investigators/designees regarding IRB submissions.
12. Independently apply the framework of applicable federal regulations, laws, guidance, and WSH IRB policies and procedures to assigned reviews.
13. Advise the research community about human subjects protection issues and institutional policies.
14. Maintain and further develop personal knowledge about applicable statutes, policies and procedures governing human subject research and related ethical codes and guidelines; continuously interpret and apply these requirements to IRB submissions and ongoing research activities.
15. Notify designated HRPP staff when guidance and/or policies require updating, including identification of policy/guidance gaps.
16. Manage pre-, intra- and post-meeting activities in partnership with the respective staff and IRB Chair, including agenda management, meeting facilitation and all aspects of IRB meeting documentation.
17. Provide technical support and guidance on regulatory matters during convened IRB meetings.
18. Serve on committees constituted to improve the functioning and climate of the HRPP.
19. Maintain awareness of institutional entities, policies, and relationships that affect HRPP and IRB operations.
20. Develop positive relationships with researchers and colleagues throughout WellSpan to facilitate compliance and greater efficiency of HRPP and IRB processes.
21. Participate in evaluation of enhancements or other modifications to the IRB and/or HRPP.
22. Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.

 Qualifications

• Notes:
  • Other combinations of formal education, training and experience may be considered.
  • Remote but needs to be within 2-3 hours of WellSpan Facilities.

 

• Minimum Experience:
  • 3 - 5 years of experience in IRB administration, clinical research or human subject protection, regulatory compliance, or research related job.

 

• Minimum Education:
  • Bachelor's Degree in biology, psychology, or other clinical research-related area.

 

• Minimum Field Of Expertise:
  • Institutional Review Board coordinator or administrative work in clinical research.

  

• Required Certification:
  • Registration: Certified IRB Professional (CIP) Certification or equivalent certification or willing to become certified within 2 years of eligibility.

 

• Skills:
  • Advanced knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators; Intermediate knowledge of clinical research; Intermediate knowledge of medical terminology; Advanced proficiency with office software (Microsoft Office) including word processing and spreadsheet software (Word, Excel); Advanced proficiency with database software; Excellent verbal and written communications skills; Strong time management skills; Strong organizational skills; Ability to gather, analyze and make recommendations/decisions based on data; Ability to convey complex or technical information in an easy to understand manner; Ability to maintain confidentiality and professionalism; Ability to work independently with minimal supervision; Ability to collaborate with stakeholders at all levels; Ability to be flexible and adaptable to change.
  • Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research. Experience in providing technical instructions to others.

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Melissa Schlenker
Corporate Director of Research
WellSpan Health
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