Under the direction of the CMP Director, the Senior Compliance Monitoring Specialist will conduct routine and priority monitoring visits and directed audits of IRB approved human subject research and prepare reports related to these activities, and serve as a resource for the JHU research community through education and training activities related to the compliant conduct of research.
Essential Job Functions:
Select, schedule and conduct routine and priority monitoring visits for IRB approved studies conducted by researchers of the Johns Hopkins University and Medical Institutions and prepare written summary reports of findings for review by the IRB. Conduct priority monitoring visits for all commercially-funded research where JHM IRB is relying on external IRB and all other greater than minimal risk research where the JHM IRB is relying on an external IRB.
Conduct priority monitoring visits for commercially-funded research activities that a) require high risk review, b) qualify for expedited review and involve an FDA-regulated drug/device, and/or c) involves a JHU held IND/IDE.
Under the supervision of the CMP Director, perform audit directed by the IRB, the Assistant Dean for Human Research Protection, the Vice Dean for Clinical Investigation, and/or other institutional representatives, and prepare written summary reports.
Conduct pre- and post- enrollment visits for sponsor investigators who hold INDs or IDEs to familiarize investigators with applicable regulatory and policy requirements and best practices to assure compliance and research quality.
Review, refine, and develop monitoring tools (including monitoring forms, SOP templates, checklists, and logs) that are part of the Compliance Monitoring Program's online Investigator Tool Kit.
Meet with principal investigators and study team members to review regulatory documents and research participant records and conduct exit interviews to discuss monitoring visit findings.
Follow-up with the principal investigator or study team members to reconcile compliance issues and provide corrective action recommendations based on best-practices or regulatory requirements.
File monitoring reports and associated documentation in the CMP network folder and enter monitoring visit data into the CMP database.
Assist the CMP Director to work with principal investigators to prepare for external (e.g., FDA) inspections and address any follow-up actions required.
Plan, develop and conduct educational activities (presentations, seminars, etc.) to improve compliance, to highlight organizational and conduct issues observed from monitoring visits, and to convey best-practices techniques to enhance compliance.
Working with the CMP Director, provide education to external sites relying on the JHM IRB about investigator responsibilities and JHM IRB requirements including reporting requirements.
Working with the CMP Director, assist the JHM IRBs serving in a single IRB capacity with the review of relying site self-assessment data to identify potential compliance concerns.
Conduct customized research compliance in-services at the request of JHM departments or divisions.
Serve as a point of contact for inquiries regarding institutional policy and FDA regulations.
Assist the CMP Director with internal audits of IRB records.
Train and mentor the Compliance Monitoring Specialists in the completion of their assigned duties.
Other regulatory duties as assigned.
Scope of Responsibility:
Responsible for monitoring and auditing IRB approved human subject research, preparing reports, and working with principal investigators and study team members to improve compliance.
The position requires independent decision-making with oversight by the Director.
Must have strong written and oral communication skills and the ability to work with faculty and staff at all levels. The position requires the ability to communicate effectively both compliance findings and corrective action recommendations to principal investigators and study-team members. The ability to deliver educational seminars to the Johns Hopkins research community is required.
BA/BS in medical research, health care related or other appropriate discipline required. Master's degree is desirable. Certification by professional organization (e.g., SoCRA, ACRP, etc.) in the area of human subjects research is preferable. Knowledge of Federal human subjects research regulations (FDA, HHS) and GCP Guidelines is essential.
Minimum 3 years auditing/monitoring or research experience with clinical trials/medical research required. Advanced education and/or training can be applied to up to one year of experience. Direct experience as a Clinical Research Associate or Research Coordinator is beneficial. Familiarity with quality assurance and/or good clinical practice principles and requirements is 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, able 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.
Classified Title: Sr. Compliance Monitoring Specialist Working Title: Sr. IRB Compliance Monitoring Specialist Role/Level/Range: ACRP/4/MD Starting Salary Range: $51, 975 - $71, 497 Employee group: Full-time Schedule: Monday - Friday Exempt Status: Exempt Location: East Baltimore-1620 McElderry Department name: Human Subjects Personnel area: SOM
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 firstname.lastname@example.org. 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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