Johns Hopkins University
Sr. Clinical Research Program Coordinator
Johns Hopkins University, Baltimore, Maryland, United States, 21276
We are seeking a
Sr. Clinical Research Program Coordinator
who will be responsible for implementing and completing Cardiology/Electrophysiology clinical trials with a high degree of independence in performance of functions. The Sr. Clinical Research Program Coordinator will maintain knowledge of study protocols and assist in the daily operations of the recruitment under the direction of the Principal Investigator and Co-Investigators and will manage and coordinate patient-related tasks of Cardiology/Electrophysiology patients participating in clinical trials. This role requires a high level of understanding and the ability to multi-task.50% of the Coordinator's time will be devoted to Patient Centered mobile Health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib), a pilot randomized clinical trial which evaluates feasibility and preliminary efficacy of the health equity centered virtual atrial fibrillation management program. Recruiting patients, onboarding them with digital health tools (Mobile App, wearable devices, etc.), and data management are among the primary responsibilities for this trial. The other 50% will be devoted to study activities for other clinical trials in the Electrophysiology department.Specific Duties & ResponsibilitiesRecruits, instructs, and coordinates research subjects to specific study objectives and work scope.Schedules study follow-up visits and research-related tests to ensure that subjects are seen in the study window timeframe to minimize protocol deviations.Implements and maintains data collection and analysis systems in support of research protocol, including management of data, paper files, subject binders and electronic databases.Ensures the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.Acts as the primary administrative point of contact for internal research staff.Processes all sponsor requests for study revisions and required reporting.Coordinates the day-to-day activities in the carrying out of research protocol, may perform aspects of research protocol in accordance with specified program objectives.Develops and maintains records of research activities and prepares periodic and ad hoc reports as required by investigators and/or regulatory bodies.Assists with reporting protocol deviations and adverse events in a timely manner.Assists with maintaining study inventory according to regulatory standards.Works with Compliance Committees and Institutional Review Boards.Assists with IRB submissions/applications. Prepares and maintains IRB and other regulatory documentation for multiple projects.Maintains compliance with Good Clinical Practice Guidelines, ICH Guidelines, IRB requirements and Federal Regulations pertaining to research.Performs miscellaneous job-related duties as assigned.Special Knowledge, Skills, & AbilitiesAbility to prioritize and coordinate multiple tasks.Ability to work well and communicate effectively with others.Strong organizational skills, attention to detail, able to work independently and as part of a team, initiative, strong leadership skills.Ability to work with a team of researchers and with diverse subject populations.Excellent oral and written communication skills.Ability to learn new database and software applications.Ability to follow multiple, detailed directions of various protocols.Excellent time management skills.Minimum QualificationsBachelor's Degree in related discipline.Three years related experience.Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.Preferred QualificationsKnowledge of medical terminology highly desired.Classified Title: Sr. Research Program CoordinatorJob Posting Title (Working Title): Sr. Clinical Research Program CoordinatorRole/Level/Range: ACRP/03/MBStarting Salary Range: $41,300 - $72,300 Annually ($56,250 targeted; Commensurate with experience)Employee group: Full TimeSchedule: M-F 8:30-5:00Exempt Status: ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM DOM CardiologyPersonnel area: School of Medicine
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Sr. Clinical Research Program Coordinator
who will be responsible for implementing and completing Cardiology/Electrophysiology clinical trials with a high degree of independence in performance of functions. The Sr. Clinical Research Program Coordinator will maintain knowledge of study protocols and assist in the daily operations of the recruitment under the direction of the Principal Investigator and Co-Investigators and will manage and coordinate patient-related tasks of Cardiology/Electrophysiology patients participating in clinical trials. This role requires a high level of understanding and the ability to multi-task.50% of the Coordinator's time will be devoted to Patient Centered mobile Health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib), a pilot randomized clinical trial which evaluates feasibility and preliminary efficacy of the health equity centered virtual atrial fibrillation management program. Recruiting patients, onboarding them with digital health tools (Mobile App, wearable devices, etc.), and data management are among the primary responsibilities for this trial. The other 50% will be devoted to study activities for other clinical trials in the Electrophysiology department.Specific Duties & ResponsibilitiesRecruits, instructs, and coordinates research subjects to specific study objectives and work scope.Schedules study follow-up visits and research-related tests to ensure that subjects are seen in the study window timeframe to minimize protocol deviations.Implements and maintains data collection and analysis systems in support of research protocol, including management of data, paper files, subject binders and electronic databases.Ensures the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.Acts as the primary administrative point of contact for internal research staff.Processes all sponsor requests for study revisions and required reporting.Coordinates the day-to-day activities in the carrying out of research protocol, may perform aspects of research protocol in accordance with specified program objectives.Develops and maintains records of research activities and prepares periodic and ad hoc reports as required by investigators and/or regulatory bodies.Assists with reporting protocol deviations and adverse events in a timely manner.Assists with maintaining study inventory according to regulatory standards.Works with Compliance Committees and Institutional Review Boards.Assists with IRB submissions/applications. Prepares and maintains IRB and other regulatory documentation for multiple projects.Maintains compliance with Good Clinical Practice Guidelines, ICH Guidelines, IRB requirements and Federal Regulations pertaining to research.Performs miscellaneous job-related duties as assigned.Special Knowledge, Skills, & AbilitiesAbility to prioritize and coordinate multiple tasks.Ability to work well and communicate effectively with others.Strong organizational skills, attention to detail, able to work independently and as part of a team, initiative, strong leadership skills.Ability to work with a team of researchers and with diverse subject populations.Excellent oral and written communication skills.Ability to learn new database and software applications.Ability to follow multiple, detailed directions of various protocols.Excellent time management skills.Minimum QualificationsBachelor's Degree in related discipline.Three years related experience.Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.Preferred QualificationsKnowledge of medical terminology highly desired.Classified Title: Sr. Research Program CoordinatorJob Posting Title (Working Title): Sr. Clinical Research Program CoordinatorRole/Level/Range: ACRP/03/MBStarting Salary Range: $41,300 - $72,300 Annually ($56,250 targeted; Commensurate with experience)Employee group: Full TimeSchedule: M-F 8:30-5:00Exempt Status: ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM DOM CardiologyPersonnel area: School of Medicine
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