Career Center

The Oncology Department seeks a Compliance Monitoring Specialist who will work under the supervision of the Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Research Compliance Manager. This role is responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures of the Cancer Center.

Specific Duties & Responsibilities

• Schedule compliance monitoring visits with research study staff. Develop protocol specific forms.
• Review research and medical records against clinical protocols for compliance.
• Prepare written summary of compliance review results.
• Meet with principal investigators and data support staff to review compliance results.
• Follow-up on results as necessary.
• Maintain scheduling and review information in CRMS for all protocol reviews.
• Help study staff to prepare for external audits.
• Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions on an as needed basis.
• Schedule compliance monitoring visits with research study staff in order to monitor studies for data integrity.
• Generate queries and conduct follow-up for non-compliance issues. Generate monitoring summary reports and communicate these findings to Investigators, Research Staff and Safety Monitoring Committee.
• Provide support for monitored trials in the form of research into regulations and review of protocols and Case report templates for protocol staff.
• Assist staff in developing corrective actions for compliance review observations when appropriate.
• Assist in training new research staff regarding research compliance, including presentations at Cancer Center education sessions.
• Participate on the CRC Sub-Committee by reviewing new studies for quality assurance and general content, coding new studies in CRMS.
• Prepare reviews of studies by the Safety Monitoring Committee. Attend and participate in SMC monthly meetings.
• Assist in the development and maintenance SOPs for the Research Manual on the CRO website as needed.
• Perform periodic compliance reviews of the Oncology Investigational Drug Service pharmacy.
• Other duties as assigned. This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned.

• BA/BS required, preferably in medical research, health care related or other appropriate discipline.
• Relevant experience may substitute for some education.
• Must be eligible for certification by professional organization in the area of human subjects' research. Current certification preferred.
• Minimum 3 year's experience with clinical trials/medical research required.
• Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred.
• Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.

Classified Title: Compliance Monitoring Specialist  
Role/Level/Range: ACRP/04/MC  
Starting Salary Range: Min $47,500 - Max $83,300 Annually ($62,225 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 830-500 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Onc Clinical Research Office  
Personnel area: School of Medicine 

Total Rewards
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 our employees' 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
Learn more:
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 accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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.

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

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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