Sr. Research Program Coordinator II

Johns Hopkins University•Baltimore, MD

16h•Hybrid

About The Position

The Sr. Research Program Coordinator II is responsible for the coordination and management of Radiation Oncology and Molecular Radiation Sciences clinical trials, working under the supervision of the Senior Clinical Research Program Manager. The role's primary duties involve effective research program and database management.

Requirements

Bachelor's Degree in related field.
Five years related experience in clinical research in an academic, government, or pharmaceutical industry environment.

Nice To Haves

Experience with JHU developed research software such as Oncore (Clinical Research Management System).
Experience using EPIC and OpenSpecimen is strongly preferred.
Experience developing REDCap as a database to track and monitor study data.
Supervisory experience and basic statistical knowledge.
Familiarity with Johns Hopkins clinical data structures advantageous.

Responsibilities

Manage all aspects of research project planning, implementation, daily administration and close out of clinical trials related to radiation oncology.
Assist in drafting new protocols, consents, case report forms, operating procedures, and other research-related documents.
Update documents as needed.
Comply with and ensure that the clinical trials team is compliant with regulatory and reporting requirements of the IRB and study sponsors including the reporting of adverse events and study deviations in coordination with the Radiation Oncology Regulatory Program Manager.
Assist in developing SOPs for the clinical trials group.
Work closely with the Budget Analyst to ensure appropriate research billing based on research participation in clinical trials including approving related invoices.
Liaison with the Principal Investigator, co-investigators, IRB staff, study monitors, study sponsors, research volunteers, and other stakeholders related to specific research studies.
Attend lectures and participate in meetings related to research and research activities.
Perform screening for enrollment, enter data into CRMS, enter data into sponsor-related and internal databases, schedule and track study visits, and coordinate activities with study sponsors, depending on study needs.
Prepare documents and reports for audits and monitoring visits.
Perform miscellaneous related duties as assigned.
Responsible for administrative, operational, functional, and security components related to research databases that will be used for multiple clinical trials in conjunction with Radiation Oncology’s IT team.
Lead research and program efforts, direct the creation and management of electronic databases such as REDCap and implement reporting and quality assurance activities in the program using technical and decision-making skills.
Oversee the compilation and transmission of data from various Johns Hopkins (Epic, Mosaic, etc.) and external database systems to Radiation Oncology’s research drive.
Ensure that all data elements are properly formatted and compiled and that the data are transmitted securely.
Work closely with the Sr. Clinical Research Program Manager on all QI initiatives on the study data.
Perform limited data analysis; provide data to biostatistician consultants for more extensive data analysis.
Participate in hiring and oversight of other personnel such as study coordinators or temporary workers, depending on needs.
Mentor or assist trainees.