Johns Hopkins University
Sr. Research Program Coordinator
Johns Hopkins University, Baltimore, Maryland, United States, 21276
We are seeking a
Sr. Research Program Coordinator
who will be responsible for implementing and completing Heart Failure with Preserved Ejection Fraction (HFpEF) clinical trials with a high degree of independence in performance of functions. As part of the study team, will collaborate with faculty, develop protocols, develop SOPs, and oversee study-related activities for multiple studies.
Specific Duties & ResponsibilitiesWork independently while engaging colleagues and supervisors at strategic or key moments.
Work independently and under the direction of the supervisor to ensure successful completion of clinical research studies.Participate in the development, implementation, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.Participate as a member of a collaborative group in study design and analysis of data.Adhere to all protocol requirements to ensure validity of clinical research data.Participate in and oversee data collection.Analyze data - organize and complete quality control checks of raw data, use standard statistical techniques and/or package programs to run standard statistics.Recruit participants in conjunction with study collaborators and study sponsors, including interacting with clinicians and other gatekeepers to access the population.Schedule participants for all activities for study visits.Complete study visits, including completion of research procedures on participants, for example,Anthropometric measurementsBlood pressureEKGSpecimen collection, including phlebotomyEnsure collection of pertinent data and maintain individual participant's binders from internal and external sources by maintaining a research chart for each research subject.Monitor and maintain supply of research supplies and order as needed.Evaluate and prepare adverse event reports and other regulatory documents.Collect, enter, and compile data from a variety of sources (including EHR) while ensuring accuracy and timeliness.Complete study case report forms.Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtain outside records when required.Obtain research meds from investigative pharmacy.Process biological samples, including appropriate handling and labeling.Ship biological samples per IATA packaging requirements.Present projects/data at meetings.Work on protocol development of sub-studies.Participate in sponsor training sessions (virtual and in person) and train other staff to ensure compliance per sponsor guidelines.Coordinate and participate in the interviewing and training of new research staff on study protocols, procedures, and reporting.Work with study sponsors on study design and/or determine what the group can commit to based on patient population, available resources, and cost of providing services.Participate in developing study budgets.Generate IRB study documents (including protocols and consent forms) and prepare IRB communications.Monitor and comply with IRB reporting deadlines.Complete contracts/arrangements for study activities (e.g. Echo, CPET, MRI, labs) for fee services.Responsible for regulatory and compliance documents for multiple sponsored clinical trials.Independently prepare for and participate in audits of studies/monitoring visits.Participate in research group meetings.Travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (JHBMC, Green Spring Station, etc.).
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 QualificationsMaster's Degree strongly preferred.Clinical research experience, including development of compliance materials, work on IRB applications, and conducting multiple studies according to ICH-GCP guidelines.
Classified Title: Sr. 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 8:30am-5:00pmExempt Status:ExemptLocation:School of Medicine CampusDepartment name: SOM DOM CardiologyPersonnel area: School of Medicine
Sr. Research Program Coordinator
who will be responsible for implementing and completing Heart Failure with Preserved Ejection Fraction (HFpEF) clinical trials with a high degree of independence in performance of functions. As part of the study team, will collaborate with faculty, develop protocols, develop SOPs, and oversee study-related activities for multiple studies.
Specific Duties & ResponsibilitiesWork independently while engaging colleagues and supervisors at strategic or key moments.
Work independently and under the direction of the supervisor to ensure successful completion of clinical research studies.Participate in the development, implementation, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.Participate as a member of a collaborative group in study design and analysis of data.Adhere to all protocol requirements to ensure validity of clinical research data.Participate in and oversee data collection.Analyze data - organize and complete quality control checks of raw data, use standard statistical techniques and/or package programs to run standard statistics.Recruit participants in conjunction with study collaborators and study sponsors, including interacting with clinicians and other gatekeepers to access the population.Schedule participants for all activities for study visits.Complete study visits, including completion of research procedures on participants, for example,Anthropometric measurementsBlood pressureEKGSpecimen collection, including phlebotomyEnsure collection of pertinent data and maintain individual participant's binders from internal and external sources by maintaining a research chart for each research subject.Monitor and maintain supply of research supplies and order as needed.Evaluate and prepare adverse event reports and other regulatory documents.Collect, enter, and compile data from a variety of sources (including EHR) while ensuring accuracy and timeliness.Complete study case report forms.Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtain outside records when required.Obtain research meds from investigative pharmacy.Process biological samples, including appropriate handling and labeling.Ship biological samples per IATA packaging requirements.Present projects/data at meetings.Work on protocol development of sub-studies.Participate in sponsor training sessions (virtual and in person) and train other staff to ensure compliance per sponsor guidelines.Coordinate and participate in the interviewing and training of new research staff on study protocols, procedures, and reporting.Work with study sponsors on study design and/or determine what the group can commit to based on patient population, available resources, and cost of providing services.Participate in developing study budgets.Generate IRB study documents (including protocols and consent forms) and prepare IRB communications.Monitor and comply with IRB reporting deadlines.Complete contracts/arrangements for study activities (e.g. Echo, CPET, MRI, labs) for fee services.Responsible for regulatory and compliance documents for multiple sponsored clinical trials.Independently prepare for and participate in audits of studies/monitoring visits.Participate in research group meetings.Travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (JHBMC, Green Spring Station, etc.).
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 QualificationsMaster's Degree strongly preferred.Clinical research experience, including development of compliance materials, work on IRB applications, and conducting multiple studies according to ICH-GCP guidelines.
Classified Title: Sr. 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 8:30am-5:00pmExempt Status:ExemptLocation:School of Medicine CampusDepartment name: SOM DOM CardiologyPersonnel area: School of Medicine