Sr. Research Compliance Monitoring Specialist (DOM Infectious Disease)

Johns Hopkins University•Baltimore, MD

2d•Hybrid

About The Position

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.

Requirements

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.

Responsibilities

Independently select, schedule, and conduct routine and priority monitoring reviews as outlined in each study-specific Monitoring Plan.
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.
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.
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.
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.
Design and deliver educational programs/materials for the TOID CRC as part of the Center’s commitment to ongoing education.
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.