The Johns Hopkins University
Research Program Coordinator
The Johns Hopkins University, Baltimore, Maryland, United States, 21276
We are looking for a bright, hardworking
Research Program Coordinator
to join our group as an integral part of our clinical research team. Under the supervision of the Principal Investigator and Research faculty, the Clinical Research Coordinator is responsible for administrative, regulatory, operations support, and data collection/maintenance for ongoing clinical research studies. The primary responsibility will be to serve as the clinical coordinator for a randomized, placebo-controlled, double-blinded study assessing the efficacy of a novel therapy for peripheral nerve injuries. The study duration is 4 years with funding secured from the Department of Defense. There may also be responsibilities to assist with other studies when time permits. The position requires precision in the documentation of clinical data, research subject scheduling, informed consent, and miscellaneous administrative responsibilities. The Clinical Research Coordinator will assist with orientation of less senior research staff in all areas of clinical research, including protocol information published by specific cooperative groups and by federal agencies. Will assist with general operations of the program.Specific Duties & ResponsibilitiesCoordinate assigned protocols, including patient enrollment, data abstraction, case report form completion and submission, specimen shipping, and other protocol-related tasks.Two years of prior clinical research coordination or nursing experience required.Must be comfortable working with patient populations.Ability to read, write, speak, and understand English.Interact with principal investigators, co-investigators and nurses as required by the protocols, providing support and protocol updates as required.Work with the research pharmacy to facilitate patient orders, drug shipment, and drug data sheet updates.Maintain electronic regulatory files and standard medical research charts for trial patients.Attain a high level of expertise in institutional databases including EPIC, CRMS, eIRB.Organize and lead study initiation meetings with principal investigators and staff.Review and analyze new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.Participate in staff meetings as a lead coordinator, preparing study progress reports for discussion, creating agendas, and scheduling space as needed.Assist the Research Manager with program operations – providing suggestions for improved procedures, creating checklists and SOPs.Coordinate audits, assisting with preparation, scheduling, and chart pre-review.Some national travel may be required to attend study program-related meetings.Complete minimum requirements for continuing education units.Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and JHM IRB policies.Screen, consent, and enroll study participants.Monitor participants during visits, perform data collection, quality assurance checks for data completion. Schedule participants, laboratory tests, medical examinations and consultations as needed per study protocol.Maintain accurate information on each study participant.Conduct telephone and in-person interviews following all protocol and HIPAA rules.May also perform laboratory specimen processing, storage and shipment using approved biosafety procedures.Perform miscellaneous related duties as assigned.Minimum QualificationsBachelor's Degree in a related discipline.Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.Preferred QualificationsClinical research experience.Experience using REDCap.Experience using Microsoft Word and Excel.Experience working with electronic medical records.Classified Title: Research Program CoordinatorRole/Level/Range: ACRO40/E/03/CDStarting Salary Range: $17.20 - $30.30 HRLY ($47,840 targeted; Commensurate with experience)Employee group: Full TimeSchedule: Monday-Friday 8am-4:30pmExempt Status: Non-ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM PRS ResearchPersonnel area: School of Medicine
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Research Program Coordinator
to join our group as an integral part of our clinical research team. Under the supervision of the Principal Investigator and Research faculty, the Clinical Research Coordinator is responsible for administrative, regulatory, operations support, and data collection/maintenance for ongoing clinical research studies. The primary responsibility will be to serve as the clinical coordinator for a randomized, placebo-controlled, double-blinded study assessing the efficacy of a novel therapy for peripheral nerve injuries. The study duration is 4 years with funding secured from the Department of Defense. There may also be responsibilities to assist with other studies when time permits. The position requires precision in the documentation of clinical data, research subject scheduling, informed consent, and miscellaneous administrative responsibilities. The Clinical Research Coordinator will assist with orientation of less senior research staff in all areas of clinical research, including protocol information published by specific cooperative groups and by federal agencies. Will assist with general operations of the program.Specific Duties & ResponsibilitiesCoordinate assigned protocols, including patient enrollment, data abstraction, case report form completion and submission, specimen shipping, and other protocol-related tasks.Two years of prior clinical research coordination or nursing experience required.Must be comfortable working with patient populations.Ability to read, write, speak, and understand English.Interact with principal investigators, co-investigators and nurses as required by the protocols, providing support and protocol updates as required.Work with the research pharmacy to facilitate patient orders, drug shipment, and drug data sheet updates.Maintain electronic regulatory files and standard medical research charts for trial patients.Attain a high level of expertise in institutional databases including EPIC, CRMS, eIRB.Organize and lead study initiation meetings with principal investigators and staff.Review and analyze new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.Participate in staff meetings as a lead coordinator, preparing study progress reports for discussion, creating agendas, and scheduling space as needed.Assist the Research Manager with program operations – providing suggestions for improved procedures, creating checklists and SOPs.Coordinate audits, assisting with preparation, scheduling, and chart pre-review.Some national travel may be required to attend study program-related meetings.Complete minimum requirements for continuing education units.Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and JHM IRB policies.Screen, consent, and enroll study participants.Monitor participants during visits, perform data collection, quality assurance checks for data completion. Schedule participants, laboratory tests, medical examinations and consultations as needed per study protocol.Maintain accurate information on each study participant.Conduct telephone and in-person interviews following all protocol and HIPAA rules.May also perform laboratory specimen processing, storage and shipment using approved biosafety procedures.Perform miscellaneous related duties as assigned.Minimum QualificationsBachelor's Degree in a related discipline.Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.Preferred QualificationsClinical research experience.Experience using REDCap.Experience using Microsoft Word and Excel.Experience working with electronic medical records.Classified Title: Research Program CoordinatorRole/Level/Range: ACRO40/E/03/CDStarting Salary Range: $17.20 - $30.30 HRLY ($47,840 targeted; Commensurate with experience)Employee group: Full TimeSchedule: Monday-Friday 8am-4:30pmExempt Status: Non-ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM PRS ResearchPersonnel area: School of Medicine
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