Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.
The Department of Neurology is seeking a Compliance Monitoring Specialist for the BIOS division in the School of Medicine. This position ensures quality, accuracy, and integrity of multi-center clinical trial data through risk-based remote monitoring and compliance oversight, supporting BIOS CTCC’s mission to advance neurological research. The Compliance Monitoring Specialist is 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.
- Conducts routine monitoring visits (remote and on-site) using established tools and checklists and documents findings.
- Assists with preparing studies and documentation for internal and external audits and inspections.
- Tracks and follows up on identified findings to support timely resolution and compliance improvement.
- Supports maintenance of monitoring trackers, logs, and reporting tools to ensure audit readiness.
Minimum Qualifications
- Bachelor’s Degree.
- Three years of related experience with clinical trials/medical research.
- Eligible for certification by a professional organization in human subjects research.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond a 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 subjects research.
Technical Skills & Expected Level of Proficiency
- Clinical Documentation Review - Intermediate
- Data Analysis - Intermediate
- Documentation - Intermediate
- Project Management - Intermediate
- Regulatory Compliance - Intermediate
- SOP Development - Intermediate
- Training and Development - Intermediate
Classified Title: Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually ($55,800
targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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