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 at Sibley Memorial Hospital.

Major duties are related to effective research program and database management.

Specific Duties & Responsibilities

Research Program Management Duties and Responsibilities

• Work collaboratively with an engaging and dynamic pediatric radiation oncology team, including physicians, nurses, and statisticians, with unique opportunities to learn about pediatric brain tumors and pediatric bone and soft tissue tumors.
• Excellent communication and written skills with the ability to communicate and collaborate with individuals within the study team and the clinical team.
• Interact directly with patients in clinic.
• Receive training from pediatric neuropsychologist to aid in administering computerized neurocognitive testing.
• 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 Program Manager.
• Assist in developing Standard Operating Procedures for the clinical trials group.
• Work closely with the Budget Analyst to ensure appropriate research billing is 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, directs the creation and management of electronic databases such as REDCap and implements 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 Radiation Oncology Program Manager on all QI initiatives on the study data.
• Perform limited data analysis; provide data to biostatistician consultants for more extensive data analysis.

Supervise

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

Minimum Qualifications

• Bachelor's Degree in related discipline. Related Master's preferred.
• Five years related experience.
• Experience in clinical study implementation and coordination.
• Facility with basic medical information to interact effectively with clinical data systems and statistical personnel involved in the project.
• Experience with MS Excel, MS Word, MS PowerPoint.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Experience with JHU developed research software such as CRMS (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.

Classified Title : Sr. Research Program Coordinator II

All potential candidates should read through the following details of this job with care before making an application.

Role / Level / Range : ACRP / 04 / MC

Starting Salary Range : $48,000 - $84,100 Annually ($65,000 targeted; Commensurate with experience)

Employee group : Full Time

Schedule : M-F, 8 : 30am - 5 : 00pm

Exempt Status : Exempt

Location : District of Columbia

Department name : SOM Rad Onc Clinical Trials Group

Personnel area : School of Medicine

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