Sr. Compliance Monitoring Specialist - Johns Hopkins Hospital : Job Details

The Johns Hopkins Center for Indigenous Health isseeking a Sr. Compliance Monitoring Specialist. There are several Institutional Review Boards (IRBs) that we report to and interact with to conduct our work. The Sr. Compliance Monitoring Specialist is an integral member of the research team and is responsible for all interactions with the various IRBs. This individual serves as the Center's expert on IRB and regulatory requirements and will lead all IRB related activities at the Center. The Sr. Compliance Monitoring Specialist will help prepare and submit initial proposals, annual and quarterly reports, amendments to protocols, manuscripts, and abstracts to all IRBs. The Sr. Compliance Monitoring Specialist will work closely with all levels of Center and tribal constituencies and will be expected to work independently and exercise excellent judgment and discretion. This position will work with existing systems to ensure smooth IRB processes, develop new systems as needed, and oversee the IRB-related work of the Center.

Specific Duties & Responsibilities

• In cooperation with relevant staff and institutional officials, will work to interpret and apply all aspects of pertinent tribal government regulations and institutional policies pertaining to human subject's research and related matters.
• Review applications submitted to the IRBs to identify deficiencies under tribal, state and federal laws and regulations, and institutional policies that must be corrected prior to IRB review.
• Determine that appropriate protocol and application-specific documentation is submitted, e.g., requests for waiver of consent, waiver of HIPAA authorizations, formal communications from the FDA or commercial sponsors.
• Assist in the review of IRB action outcomes, including the IRB's minutes where required, and determine that regulatory, and policy issues and their outcomes are documented appropriately.
• Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist faculty and staff with regulatory documentation issues.
• Provide ongoing regulatory guidance to Center investigators and study team members.
• Lead regulatory strategic planning meetings with faculty to assist with protocol planning and addressing complex regulatory issues that may arise as part of the IRB submission and review process.
• Develop and lead educational offerings for Center faculty and staff, Fellows, Post-docs, IRB members and Chairs, and tribal stakeholders as requested.
• Independently conduct a review of select research applications (new applications, further study actions, relevant single IRB applications) and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
• Read, understand, and write scientific protocols, informed consent forms, SOPs, etc.
• Translate scientific information.
• Frequently exchanges information using tact and confidentiality as appropriate requiring strong oral and written communication skills. Often maximizes these skills to express, both orally and in writing, the mission and vision of the Center.
• Exercises sound administrative judgement and assumes responsibility for decisions, consequences, and results having an impact on people and the quality of service within the functional area.

• Exercises a superior level of customer service.
• Perform other duties as required related to human subject's research practice, as requested by the Principal Investigators and Directors.

Additional Knowledge, Skills & Abilities

• Working knowledge of Good Clinical Practice or willingness to be trained on GCP.

• Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations, as well as the ethical considerations related to that subject.
• Ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods.
• Good analytical writing and verbal communication skills.
• Knowledge of the ethical principles and regulations relevant to human subject's research and IRB processes.
• Familiarity with Tribal IRB processes.
• Demonstrated ability to work independently, exercise sound judgment, and multi-task.
• Ability to communicate in a professional, positive, and persuasive manner.
• Ability to work as a team member, be very detail-oriented, and communicate with faculty and staff both internal and external to the institution at all levels.
• Strong administrative/coordination skills.
• Experience in high volume office and ability to meet time sensitive processing deadlines. Ability to work in a fast-paced and demanding environment and able to manage multiple tasks effectively.
• Must be proficient, or able to become proficient in all applicable software applications.
• Computer, must be proficient, or able to become proficient in all applicable software applications.

• Bachelor's Degree in related field.

• Five years related experience in research administration or clinical trials/medical research. Knowledge of federal human subjects research regulations (FDA,HHS) and GCP guidelines.

• Native language speaker.
• Ability to translate technical medical terminology and concepts into relatable language and examples.
• Knowledge of local geography and culture, prior work experience in this community.
• Prior research experience.

Classified Title: Sr. Compliance Monitoring Specialist Job Posting Title (Working Title):Sr. Compliance Monitoring Specialist Role/Level/Range: ACRP/04/MD Starting Salary Range: $55,800 - $97,600 Annually (Commensurate w/exp.) Employee group: Full Time Schedule: Monday to Friday: 8:00 am - 4:30 pm FLSA Status:Exempt Location:MD - Other Location Department name: 10001145-Center for Indigenous Health Personnel area: School of Public Health

Total Rewards The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here:

Education and Experience Equivalency Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEOis the Law

Accommodation Information 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 Talent Acquisition Office at [email protected]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit

Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine.The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit all other JHU applicants should visit

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. 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.