Johns Hopkins University
Sr. Research Program Coordinator II
Johns Hopkins University, Washington, District of Columbia, us, 20022
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
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
Equal Opportunity Employer:
Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.
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
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
Equal Opportunity Employer:
Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.