Compliance Associate Jobs in Maryland

INTRODUCTION

The Office of Human Subjects Research is seeking a Human Research Compliance Associate to provide regulatory and compliance advice to the Johns Hopkins University Institutional Review Boards (JHU IRBs). This includes applicable federal, state, and local laws and regulations and institutional policies relating to the protection of human subjects in research conducted at or through JHU. This role provides advice to investigators, research staff, and other members of the broader JHU human research community, including researchers at non-Hopkins sites relying on the review of the JHU IRBs.

Specific Duties & Responsibilities

• Interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects research and related matters.
• Review applications submitted to the IRBs to identify deficiencies under federal and state 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, legal, and policy issues and their outcomes are documented appropriately.
• Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.
• Provide ongoing regulatory advice to JHU IRBs and JHU investigators and study team members.
• Lead regulatory consults 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 IRB staff, IRB members and Chairs, and JHU research teams.
• Prepare reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others.
• Independently review select research applications, e.g. new applications, further study actions, relevant single IRB applications, as an IRB member and work with faculty/research staff to identify deficiencies to correct prior to IRB approval.
• Other duties as assigned.

MINIMUM QUALIFICATIONS

• Juris Doctor (JD) from an accredited law school.
• Member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state), or eligible to sit for the bar exam; continued employment is contingent upon passing the bar exam within one year of start date.
• 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

• Three years of compliance or administrative experience related to human subjects research.

Classified Title: Human Research Compliance Associate

Role/Level/Range: ATP/04/PE

Starting Salary Range: $73,300 - $128,300 Annually ($85,000 Starting salary)

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

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.