Classified Title: IRB Compliance Monitoring Specialist Working Title: IRB Compliance Monitoring Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $44,749 - $61,610 Employee group: Full Time Schedule: M-F 8:30 a.m. - 5:00 p.m. Exempt Status: Exempt Location: 1620 McEdlerry St, Reed Hall B-130 Department name: 10002712-SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
Under the supervision of the Compliance Monitoring Program Director, the Compliance Monitoring Specialist will work with the Senior Compliance Monitoring Specialists to conduct routine internal monitoring of IRB approved human subject research and prepare summary reports. In addition, the Compliance Monitoring Specialist may engage in other monitoring activities, as directed, and participate in educational and training seminars offered to the Johns Hopkins University research community.
Essential Job Functions
Schedule and conduct, random routine monitoring visits for IRB approved studies across all divisions of Johns Hopkins School of Medicine.
Conduct pre and post enrollment visits for IND/IDE sponsor investigators to
review the available FDA required documentation for completeness and accuracy,
familiarize investigators with applicable regulations that apply to proper conduct,
discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records.
Prepare written reports to summarize routine and IND/IDE pre/post enrollment findings for review by the Institutional Review Board.
Review regulatory materials and research participant records
Conduct exit interviews with the study team and investigator to discuss monitoring visit findings and address any questions.
Follow-up with the principal investigator or study team members to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices.
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 point of contact 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
Scope of Responsibility
Responsible for monitoring IRB approved human subject research, preparing reports, and working with principal investigators and study team members to assess and, if required, improve research compliance.
The Mission of the Office of Human Subjects Research is to uphold the highest standards for conduct of protocols, and this provides the authority to schedule and perform monitoring visits.
The Compliance Monitoring Specialist must have strong written and oral communication skills and the ability to work with JHU SOM faculty and staff at all levels. The position requires the ability to communicate clearly both compliance findings and corrective action recommendations to principal investigators and study-team members.
BA/BS in medical research, health care related or other appropriate discipline required. Closely related experience may be substituted for education, to the extent permitted by the JHU equivalency formula. A working knowledge of federal human subjects research regulations is required.
At least 1 year direct experience as a Clinical Research Associate or Research Coordinator, that includes experience with quality assurance and/or good clinical practice monitoring is required. Minimum 2 years research experience with clinical trials/medical research is required. General familiarity with Federal and Institutional research requirements and guidelines is also required.
Excellent organizational and interpersonal skills required.
Ability to work independently and exercise judgment.
Must have strong oral and written communication skills.
Must be a team player
Ability to work in fast paced and demanding environment and able to manage multiple tasks effectively.
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Communication skills using the spoken word.
Ability to see within normal parameters.
Ability to hear within normal range.
Ability to move about.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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