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We are seeking a **_Compliance Monitoring Specialist_** who will be responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures.

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 OnCore for all protocol reviews.

+ Help study staff to prepare for external audits.

+ Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions as needed.

+ Schedule compliance monitoring visits with research study staff to monitor data integrity studies.

+ Generate queries and conduct follow-up for non-compliance issues.

+ Generate monitoring summary reports and communicate these findings.

+ 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; may make presentations to support this effort.

+ Participate on subcommittees by reviewing new studies for quality assurance and general content, and coding new studies.

+ Prepare reviews of studies by various committees.

+ Attend and participate in monthly meetings.

+ Assist in the development and maintenance of SOPs for the research manual on assigned areas website as needed.

+ Perform periodic compliance reviews.

+ Other duties as assigned.

Minimum Qualifications

+ Bachelor’s Degree.

+ Three years of related experience with clinical trials/medical research.

+ Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula

Preferred Qualifications

+ Bachelor’s Degree in Life Sciences, Health Care or a related field.

+ Certification in human subject's research.

Classified Title: Compliance Monitoring Specialist

Role/Level/Range: ACRP/04/MC

Starting Salary Range: $48,000 - $84,100 Annually ($65,400 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon - Fri / 8a - 4:30p

FLSA Status: Exempt

Department name: SOM Onc Clinical Research Office

Personnel area: School of Medicine

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.