The Johns Hopkins University
Sr. Clinical Research Program Coordinator
The Johns Hopkins University, Baltimore, Maryland, United States, 21276
Sr. Clinical Research Program Coordinator
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. The Coordinator will maintain knowledge of study protocols and assist in the daily operations of recruitment under the direction of the Principal Investigator and Co-Investigators, managing and coordinating patient-related tasks for Cardiology/Electrophysiology patients participating in clinical trials. 50% of the Coordinator's time will be devoted to the Patient Centered mobile Health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib) pilot randomized clinical trial, which evaluates feasibility and preliminary efficacy of a health equity-centered virtual atrial fibrillation management program. Responsibilities include recruiting patients, onboarding them with digital health tools (Mobile App, wearable devices, etc.), and data management. The other 50% will focus on study activities for other clinical trials in the Electrophysiology department.Specific Duties & ResponsibilitiesRecruits, instructs, and coordinates research subjects to meet specific study objectives.Schedules study follow-up visits and research-related tests to ensure that subjects are seen within the study window timeframe.Implements and maintains data collection and analysis systems in support of research protocols, including management of data, paper files, subject binders, and electronic databases.Ensures smooth and efficient day-to-day operation of research and data collection activities in compliance with 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 day-to-day activities in carrying out research protocols, performing aspects of research 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.Maintains study inventory according to regulatory standards.Works with Compliance Committees and Institutional Review Boards.Assists with IRB submissions/applications 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 communicate effectively with others.Strong organizational skills, attention to detail, and ability to work independently and as part of a team.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 a related discipline.Three years of 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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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. The Coordinator will maintain knowledge of study protocols and assist in the daily operations of recruitment under the direction of the Principal Investigator and Co-Investigators, managing and coordinating patient-related tasks for Cardiology/Electrophysiology patients participating in clinical trials. 50% of the Coordinator's time will be devoted to the Patient Centered mobile Health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib) pilot randomized clinical trial, which evaluates feasibility and preliminary efficacy of a health equity-centered virtual atrial fibrillation management program. Responsibilities include recruiting patients, onboarding them with digital health tools (Mobile App, wearable devices, etc.), and data management. The other 50% will focus on study activities for other clinical trials in the Electrophysiology department.Specific Duties & ResponsibilitiesRecruits, instructs, and coordinates research subjects to meet specific study objectives.Schedules study follow-up visits and research-related tests to ensure that subjects are seen within the study window timeframe.Implements and maintains data collection and analysis systems in support of research protocols, including management of data, paper files, subject binders, and electronic databases.Ensures smooth and efficient day-to-day operation of research and data collection activities in compliance with 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 day-to-day activities in carrying out research protocols, performing aspects of research 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.Maintains study inventory according to regulatory standards.Works with Compliance Committees and Institutional Review Boards.Assists with IRB submissions/applications 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 communicate effectively with others.Strong organizational skills, attention to detail, and ability to work independently and as part of a team.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 a related discipline.Three years of 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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