We are seeking an IRB Compliance Monitoring Specialist who will be part of a team that supports the JHM Institutional Review Boards (IRBs). This role conducts internal compliance monitoring of IRB-approved human subject research and prepares summary reports.
Specific Duties & Responsibilities
Schedule and conduct, monitoring reviews for IRB approved studies
Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to
Review the available FDA required documentation for completeness and accuracy,
Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial,
Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records.
Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial.
During the review, prepare a written report of findings and observations.
Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices
Provide support and resources based on regulatory requirements and best practices.
Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board.
Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance.
Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions.
Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations.
Provide practical recommendations to implement strategies to increase regulatory and subject compliance
Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment.
Other duties as assigned.
Minimum Qualifications
Bachelor’s Degree.
Three years of related clinical/medical research experience.
Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Classified Title: IRB Compliance Monitoring Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 Annually ($50,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Monday - Friday 8:30am - 5:00pm FLSA Status: Exempt Location: Remote Department name: SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
The Johns Hopkins University (JHU) was founded in 1876 as the nation's first research university, dedicated to bringing the benefits of discovery to the world. JHU is the largest private employer in Baltimore and Maryland, making a large economic impact in the city and state. We enroll more than 30,000 full- and part-time students across nine academic divisions, offering in-person and remote learning in over 400 programs. Not only are we located in Baltimore, but we also have a presence in Washington, D.C.