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Johns Hopkins University Compliance Monitoring Specialist in Baltimore, Maryland

We are seeking 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.

Minimum Qualifications

  • 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 years 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: $47,500 - $83,300 Annually ($65,400 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

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.

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