Location: Baltimore, Maryland
Internal Number: 107219-en_US
The Office of Human Subjects Research is seeking an IRB Compliance Monitoring Specialist who is part of a team that supports the JHM Institutional Review Boards (IRBs). Under the supervision of the Compliance Monitoring Program Director and Associate Director, the Compliance Monitoring Specialist will work with the Senior Compliance Monitoring Specialist(s) to conduct internal monitoring of IRB approved human subject research and prepare summary reports. In addition, the Compliance Monitoring Specialist may engage in other monitoring activities, as directed, and participate in educational and training seminars offered to the Johns Hopkins University research community.
*This position has been designated as a 100% remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.
Specific Duties & Responsibilities
- Schedule and conduct, monitoring reviews for IRB approved studies across all divisions of Johns Hopkins School of Medicine.
- Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to
- Review the available FDA required documentation for completeness and accuracy,
- Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial,
- Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records.
- Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial.
- During the review, prepare a written report of findings and observations.
- Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices
- Provide support and resources based on regulatory requirements and Best Practices.
- Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board.
- Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance.
- Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions.
- Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations.
- Provide practical recommendations to implement strategies to increase regulatory and subject compliance
- Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment.
- Other duties as assigned.
- 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.
- Ability 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, including transportation of a laptop computer and files.
**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.
- B.S. /B.A. in medical research, health care related or other appropriate discipline required. Closely related experience may be substituted for education, to the extent permitted by the JHU equivalency formula.
- Minimum 2 years research experience with clinical trials/medical research is required. General familiarity with federal research requirements and guidelines, including requirements for human research protections is also required.
- Requires good analytical and writing skills.
- At least 1-year direct experience as a Clinical Research Associate or Research Coordinator, that includes experience with quality assurance and/or good clinical practice monitoring is required.
Classified Title: IRB Compliance Monitoring Specialist
Starting Salary Range: $46,560-$64,100-$81,650 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: Monday - Friday 8:30am - 5:00pm
Exempt Status: Exempt
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports the health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
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 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.
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.
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
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@example.com. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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.
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