Compliance Program Manager Visa Sponsorship Jobs in Maryland

INTRODUCTION

The Office of Human Subjects Research is seeking a JH-ACH IRB Program Manager. The JH-ACH IRB Program Manager is responsible for oversight of the operations of the JHACH IRB Program, including the JHACH IRB Committee. As a member of the OHSR management team, the JH-ACH IRB Program Manager works closely with the Director OHSR Operations, Associate Directors of Convened and Exempt/Expedited Review, Director of Compliance, the Associate Dean for Human Research Protections Program, the IRB Chairs, and operational leaders across the Human Research Protections Program to maintain and advance efficient processing of human subject research projects at the Johns Hopkins School of Medicine.

Specific Duties & Responsibilities

• In conjunction with the OHSR Directors and OHSR management team, plan and coordinate activities in support of the OHSR IRB review processes.
• Represent the JHACH IRB Program on institutional committees and workgroups related to human subjects research activities at JHACH; serves as the JHACH IRB Program liaison on committees constituted to improve the functioning of the overall Johns Hopkins Medicine Human Research Protections Program.
• Work with the IRB Chair, IRB Members, and staff of the JHM OHSR to support the ethical review and oversight of protocols assigned to the JHACH IRB for review.
• Provide daily supervision to the staff of the JHACH IRB Program, including the IRB Analyst and Consent Form Specialist.
• Facilitate IRB investigations of noncompliance or unanticipated events involving risks to subjects or others related to research conducted at JHACH and ensures appropriate follow-up with IRB required actions in collaboration with JHM OHSR.
• Oversee preparation of reports of JHACH IRB Program activities for presentation by the JHACH Director of Research to institutional governance bodies (e.g., Executive Committee of JHACH and JHACF).
• Analyze workflows to determine the most efficient and effective processes and assist with the development and implementation of improved workflows as needed.
• Lead consultations with research teams and serve as a resource for investigators and study teams to assist with protocol planning and addressing complex operational and regulatory issues that may arise as part of the IRB submission and review process.
• On a regular and continuous basis, exercise sound judgment and assume responsibility for answering inquiries that have a direct impact on the review process of human subject research protocols.
• Participate in the revision and development of OHSR review guidelines, policies, FAQs, forms, and templates.
• Contribute to US Food and Drug Administration IRB inspection visits and Office of Human Research Protection (OHRP) visits.
• Develop and lead educational offerings for OHSR staff, IRB members and Chairs, JHM research teams, and the broader HRPP community, including targeted trainings for the JHACH research community.
• Participate in HRPP evaluation, strategic planning, and the formulation of short- and long-term goals and objectives.
• Determine congruency of grants with approved protocols using standards established by federal regulations and institutional policy.
• Attend IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.
• Review and revise IRB minutes and letters following assigned IRB meetings.
• Prepare OHRP and FDA reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others.
• Independently conduct review of select research applications (new applications and further study actions) as an IRB member and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
• Other duties as assigned related to human subjects research practice, as requested by the Associate Dean.

Remote Work Designation

This position has been designated as remote; however, the individual in this role will be expected to travel several times each year for required in-person meetings and related events. Advance notice will be provided whenever possible.

MINIMUM QUALIFICATIONS

• Bachelor's Degree.
• Five years of experience relevant to the planning, conducting or administration of human subjects research.
• Two years of supervisory experience, preferably within an academic medical environment.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/ graduation equivalent, to the extent permitted by the JHU equivalency formula.

PREFERRED QUALIFICATIONS

• Advanced Degree

Classified Title: Associate Director OHSR

Job Posting Title (Working Title): JH-ACH IRB Program Manager (Office of Human Subjects Research)

Role/Level/Range: ATP/04/PF

Starting Salary Range: $85,500 - $149,800 Annually ($95,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Monday - Friday 8:30 am - 5:00pm

FLSA Status: Exempt

Location: Remote

Department name: SOM Admin Clinical Invest Human Subjects

Personnel area: School of Medicine

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: https://hr.jhu.edu/benefits-worklife/.

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.

EEO is the Law

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

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 jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit: https://accessibility.jhu.edu/.

Vaccine Requirements

Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the 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.

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.