Compliance Monitoring Specialist

1 month ago

Baltimore, United States Johns Hopkins University Full time

Job Req ID:

113714

Compliance Monitoring Specialist

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.

Total Rewards
The referenced salary range is based on Johns Hopkins Universitys 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: .

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:

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