Human Research Compliance Associate

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Posted Date
May 16, 2022

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Position Type
Administrative, Academic Affairs, Research Administration, Business & Administrative Affairs, Chief Business Officers & Vice Presidents, Legal Affairs, Deans
Employment Type
Full Time
We are seeking a Human Research Compliance Associate (the “Associate”) who will be responsible for providing regulatory and compliance advice on a day-to-day basis to the Johns Hopkins Medicine Institutional Review Boards (JHM IRBs). This will be with respect to applicable federal, state, and local laws and regulations, and institutional policies relating to protection of human subjects in research conducted at or through JHM (collectively referring to The Johns Hopkins University and all institutions included in the JHU School of Medicine’s and the JHHS’s Federal Wide Assurances). The Associate will also be responsible for providing this advice to JHM investigators, their research staffs, and other members of the broader JHM human subjects research community, including researchers at non-Hopkins sites relying on the review of the JHM IRBs.

Specific Duties & Responsibilities:

    The Associate, in cooperation with relevant staff and institutional officials (including Counsels for JHU and JHHS, and the Associate Dean for Human Research Protections), will work to interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects research and related matters. The Associate will 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. The Associate will 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. The Associate will 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. The Associate will attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues. The Associate will provide on-going regulatory advice to JHM IRBs and JHM investigators and study team members. The Associate will 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. The Associate will develop and lead educational offerings for OHSR staff, IRB members and Chairs, and JHM research teams. The Associate will prepare OHRP and FDA reports of serious non-compliance, continuing non-compliance or unanticipated problems involving risks to participants or others. The Associate will independently conduct review of select research applications (new applications, further study actions, relevant single IRB applications) as an IRB member and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval. Perform other duties as required related to human subjects research practice, as requested by the Associate Dean or the Director.

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.

Minimum Qualifications (Mandatory):

    J.D. from an accredited law school and a member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state). Minimum of 3 years of compliance or administrative experience relevant to human research studies is highly desirable.

* 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.

Reporting Relationships

    The position will report to the Associate Director of Compliance in the Office of Human Subjects Research (OHSR). The Associate also will work closely with the Director of Compliance, the Associate Dean for Human Research Protections, General Counsels for JHU and JHHS, and the Vice Dean for Clinical Investigation.

Special Knowledge, Skills & Abilities:

    Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations as well as the ethical considerations related to that subject highly desirable. The Associate must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods, and possess exemplary writing and verbal skills. Experience in group process and dynamics is valuable in this position.

Physical Requirements

    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.

Remote Work Designation

    This position has been designated as a remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.

Classified Title: Human Research Compliance Associate
Role/Level/Range: ATP/04/PE
Starting Salary Range: Commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30 - 5:00
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. 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. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf


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 jhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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