Sr. Research Compliance Monitoring Specialist (DOM Infectious Disease)

We are seeking a Sr. Research Compliance Monitoring Specialist who will serve as the lead for single- and multi-center funded research within the Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC). This role involves reviewing study conduct and documentation, guiding corrective actions, collaborating with external partners/academic centers, and supporting the onboarding and offboarding of participating study sites. This position contributes to the development of standard operating procedures (SOPs), internal and external staff training, audit preparation, and serves as a research regulatory resource. Our research focuses on solid organ transplantation and in particular, novel transplantation practices such as organ donation from donors with HIV and hepatitis C.

Specific Duties and Responsibilities

Monitoring

• Independently select, schedule, and conduct routine and priority monitoring reviews as outlined in each study-specific Monitoring Plan. Most reviews are conducted remotely and include evaluating regulatory documentation and participant records, meeting with investigators and study teams, and holding a close-out discussion to review findings and develop corrective action plans as needed.
• Monitor federally and commercially funded studies. Assign data queries and work with participating sites to ensure they are addressed within a timely manner.
• Document findings in formal summary reports, file supporting documentation, and maintain records as outlined in the Monitoring Plans and internal SOPs. Conduct follow-up monitoring meeting with PI to review results, address issues or concerns that were identified, and answer study specific questions.
• Assist in screening adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported appropriately to sponsor and IRBs within specific reporting time frames as required.
• Assist in the development and editing of study-specific Monitoring Plans and other study-specific documents.

IRB Monitoring

• Assist TOID CRC Project Managers with coordination and review of continuing review submissions for multi-site studies where the JHM serves as the reviewing IRB.
• Engage with participating sites to resolve IRB application issues, ensure timely and accurate submissions, and educate sites relying on JHM IRB of requirements, including reporting of AEs and protocol deviations.

TOID CRC Operations & Quality Assurance

• Evaluate and enhance internal monitoring workflows and tools.
• Develop and revise SOPs and job aids in collaboration with TOID CRC leadership and frontline staff.
• Lead and/or participate in internal quality improvement audits and update TOID CRC team on procedural changes.
• Support the development and maintenance of compliance tools (e.g., checklists, templates, logs) housed on the study specific Share Drive.

TOID CRC Education & Outreach

• Design and deliver educational programs/materials for the TOID CRC as part of the Center's commitment to ongoing education. These programs/materials will be focused on research compliance, best practices, and internal quality improvement.
• Serve as a point of contact for inquiries regarding study-specific regulatory and protocol-related questions for internal and external collaborators.
• Other duties as assigned.

• Bachelor's Degree.
• Five 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 a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Classified Title: Sr. Compliance Monitoring Specialist
Job Posting Title (Working Title):Sr. Research Compliance Monitoring Specialist (DOM Infectious Disease)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($77,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30am-5pm
FLSA Status:Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Infectious Disease
Personnel area: School of Medicine