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Institutional Review Board Coordinator (Full Time/ Day shift)


Summary

Job Description

POSITION SUMMARY: Performing compliance functions as related to human subjects research and administrative support to the Institutional Review Board (IRB).

LOCATION: Lancaster, PA

HOURS: Full Time (1.0 FTE; 40hrs/wk) standard day shift - 8 hours (plus 30 minute lunch) between approximate hours of 7 AM and 6 PM.

ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:

  • Conducts preliminary reviews of applications, including informed consent documents, questionnaires and advertisements, to the Institutional Review Board (IRB) for proposed research using human subjects to determine consistency with IRB policies/procedures and federal guidelines. Alerts IRB to potential for problems, issues, changes, regulatory or historical factors for consideration.
  • Serves as the primary resource for investigators regarding the IRB policy/procedural requirements for human research protocols. Tracks pending applications and advises investigators on the status of their protocols and on office-established procedures to assist investigators in complying with conditions imposed by the committee. Identifies and tracks approved research protocols.
  • Supports the IRB chair and vice-chair in activities having to do with their positions.
  • Assigns reviewers, prepares agendas, supplies required documents and information to the committee in advance of meetings, records minutes of complex committee meetings, and composes large volume of in-depth analytical correspondence based on committee deliberations.
  • Composes correspondence associated with reviews, IRB decisions, requests and other appropriate IRB actions.
  • Prepares and maintains all IRB meeting documents and files in compliance with all applicable regulations.
  • Prepares IRB annual report.
  • Maintains content of IRB electronic database.
  • Maintains IRB templates and checklists.
  • Supports activities related to human subject protections program accreditation; compiles policies and supporting documents, coordinates site visits, and distributes correspondence from accreditation agency.
  • Supports internal and external audits of IRB records.
  • Provides support for IRB website.
  • Analyzes and applies Federal and State regulations regarding human subject protection policies and procedures in conjunction with consultation of Legal Services and the Executive Director of the Research Institute.
  • Maintains competence with applicable regulations and guidelines through continuing education. Attends national conferences and or meetings appropriate for IRB administrative functions.
  • Manages the monitoring activities of the human subjects protection program; conducts on-site reviews of LG Health research studies for compliance with institutional policies and procedures and generates reports.
  • Manages the training and education activities of the human research protection program; tracks certification of research personnel.
  •   Manages research-related financial disclosures for the human research protection program; tracks completion of required disclosure documents, tracks decisions by the Research Compliance Committee on management of conflicts of interest.
  •   Reports on monitoring, training and education, and conflict of interest management to the IRB and/or the Research Compliance Committee as required.

SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:

  • Helps make arrangements and preparations for IRB-related travel, conferences, appointments, special events or other business activities including budgetary input.
  • Assists in preparing education materials for presentation.
  • Assists with photocopying and the preparation of IRB meeting materials.
  • Communicates information about updated policies and procedures.
  • Performs other related duties as assigned.
  • Other duties as assigned.

JOB REQUIREMENTS

MINIMUM REQUIRED QUALIFICATIONS:

  • Bachelor’s degree in related field
  • Certified IRB Professional (CIP) credentialing or willingness to seek credentialing

OR

  • High school diploma or equivalent (GED)
  • Ten (10) years’ experience in Institutional Review Board / Human Research Protection Program coordination
  • Certified IRB Professional credentialing

Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job.  It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards.  The percentages of time spent performing job duties are estimates, and should not be considered absolute.  The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole.  Incumbent must be able to perform all job functions safely.

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Benefits At A Glance:

PENN MEDICINE LANCASTER GENERAL HEALTH offers the following benefits to employees:

  • 100% Tuition Assistance at The Pennsylvania College of Health Sciences
  • Paid Time Off and Paid Holidays
  • Shift, Weekend and On-Call Differentials
  • Health, Dental and Vision Coverage
  • Short-Term and Long-Term Disability
  • Retirement Savings Account with Company Matching
  • Child Care Subsidies
  • Onsite Gym and Fitness Classes

Disclaimer

PENN MEDICINE LANCASTER GENERAL HEALTH is an Equal Opportunity Employer, committed to hiring a diverse workforce. All openings will be filled based on qualifications without regard to race, color, sex, sexual orientation, gender identity, national origin, marital status, veteran status, disability, age, religion or any other classification protected by law.

 

Search Firm Representatives please read carefully: PENN MEDICINE LANCASTER GENERAL HEALTH is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at PENN MEDICINE LANCASTER GENERAL HEALTH via-email, the Internet or directly to hiring managers at Penn Medicine Lancaster General Health in any form without a valid written search agreement in place for that position will be deemed the sole property of PENN MEDICINE LANCASTER GENERAL HEALTH, and no fee will be paid in the event the candidate is hired by PENN MEDICINE LANCASTER GENERAL HEALTH as a result of the referral or through other means.

LGH Full Time Posted on 06/23/2022