Sr. Research Program Coordinator II

We are seeking a Sr. Research Program Coordinator II who will be responsible for the coordination and management of Radiation Oncology and Molecular Radiation Sciences clinical trials under the supervision of the Senior Clinical Research Program Manager. Major duties are related to effective research program and database management.

Research Program Management Duties and Responsibilities

• Manage all aspects of research project planning, implementation, daily administration, and closeout 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.
• Ensure compliance 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.
• Depending on study needs, 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.
• Prepare documents and reports for audits and monitoring visits.
• Perform miscellaneous related duties as assigned.

Database Duties and Responsibilities

• 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, directing the creation and management of electronic databases such as REDCap and implementing 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 is 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.

• Depending on needs, may participate in hiring and oversight of other personnel such as study coordinators or temporary workers.
• May mentor or assist trainees.

• Bachelor's Degree in a related field.
• Five years related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Experience with JHU developed research software such as Oncore (Clinical Research Management System).
• Experience using EPIC and Open Specimen 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.