Human Research Protection Program & IRB Manager
POSITION SUMMARY: Responsible for administration of the Human Research Protection Program (HRPP) and accreditation, management of the Institutional Review Board (IRB) functions and processes, and HRPP quality assurance activities throughout LG Health. Interacts with investigators, coordinators, IRB members, regulatory and other staff regarding research training, HRPP requirements and resources, and monitoring.
LOCATION: Lancaster, PA
HOURS: Full Time (1.0 FTE; 40hrs/wk)
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
- Manages the Institutional Review Board (IRB) administrative functions, staff, operations and data management.
- Oversees use and customization of IRB management system. Generates reports and performance metrics from IRB management system.
- Serves as first-line resource to investigators wanting to conduct research; navigates investigators through the IRB requirements/submission process, counsels on human subject protections and research quality.
- Organizes regular meetings of the HRPP leadership group, develops meeting agenda and materials, takes and distributes minutes.
- Gathers input on HRPP policies, drafts revisions, brings revisions to the HRPP leadership group for approval, and makes updates to the posted HRPP policy manual.
- Manages creation of annual reports and required status reports for AAHRPP accreditation.
- Leads HRPP in formal evaluation process required for accreditation.
- Coordinates application efforts for re-accreditation process.
- Manages the training and education activities of the human subject protection program; tracks certification of research personnel.
- Manages research-related conflict of interest disclosure for the human subject protection program; tracks completion of required disclosure documents.
- 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.
- Reports on monitoring, training and education, and conflict of interest disclosure to the IRB and/or the Research Compliance Committee as required.
- Manages applications for renewal of human subject protection program accreditation.
SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:
- Maintains professional/technical growth and development through in-service meetings, seminars, conferences to keep abreast of new developments.
- Participates on committees and attends meetings as directed.
- Other duties as assigned.
MINIMUM REQUIRED QUALIFICATIONS:
- Bachelor’s degree in a business, science, public health or related area.
- Five (5) years’ experience in field of clinical research or related area within healthcare.
- Experience with HRPP/IRB administration, regulatory and HRPP accreditation.
- Proficient computer skills and demonstrated application of those skills relative to job experience in database design, software/system administration, spreadsheet, word-processing and multimedia applications.
- Master’s degree in a business, science, public health or related area.
- Three years experience in research, quality assurance or performance improvement.
- One year experience in software/database administration.
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.
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
Posted on 06/23/2022
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.