The Johns Hopkins University
Clinical Trials Project Manager
The Johns Hopkins University, Baltimore, Maryland, United States,
The Department of Neurology is seeking a
Clinical Trials Project Manager (CTPM)
to join the research team in the division of Neuroimmunology. The Manager will utilize their clinical trials background to liaise, communicate, and perform duties in support of the PI and their multicenter clinical trial. As a senior member of the team, you will work alongside the clinical research team and the PI in the conduct and execution of clinical research projects. Will manage research trials for the clinical research program. The CTPM will maintain a good working knowledge of assigned protocols and projects and their reporting requirements. The position reports directly to the Principal Investigator.Specific Duties & ResponsibilitiesOversee all aspects of start-up and conduct of an investigator-initiated multi-center clinical trial.Participate in investigator meetings, site development and start up meetings with sponsoring agencies.Clarify concerns and questions about new protocols in collaboration with PI and other sites.Participate on conference calls with other participating sites regarding status of clinical trials and site selection meetings.Work with PIs in defining information and plans required to accomplish goals of studies.Ensure smooth implementation of new trials from initial contact through study activation.Serve as central resource for clinical trials group, including the development of guidelines/templates for protocol development to ensure that all regulations are followed in both the development and implementation of clinical trials.Collaborate in the development of consent forms and preparation of regulatory documents.Design and create protocol specific case report forms and assist less experienced staff in design and creation of forms.Prepare and submit multi-pronged internal and external advertisement and participant recruitment plan which may include radio, local health events, partnership with local associations pertaining to disease category and publications and/or web sites.Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to clinical trials.Track each submission through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement system to decrease delays in the trial approvals, and intervene as required to facilitate approval process.Design and compile training materials which aid physicians and staff in complying with protocol requirements.Develop and maintain a protocol database and/or spreadsheets for tracking patient activity, data collection, and financial management.Collect, monitor, organize and maintain all clinical research data.Ensure data accuracy and validity for complex and detailed clinical trials in adherence to all protocol requirements.Ensure timeliness of data so that information may be used by physicians in treatment planning for individual patients, and by the PI for grant writing, presentations and publication.Participate in data analysis.Train and provide oversight of research data management and regulatory issues within the research program.Maintain regulatory binders for assigned protocols.Prepare IRB submissions, initiate and supervise study regulatory files.Function as a liaison with the IRB and Clinical Research Office and other research administration offices.Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and sponsor requirements.Plan and prepare for regular monitoring visits.Prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits.Collaborate with JHU based staff, investigators, regulatory bodies, and sponsoring organizations to resolve study-related needs.Meet with department financial management and understand invoicing for laboratory tests and protocol events defined in the financial contract.Participate in the development of invoicing schedules.Research cost of medical procedures for clinical trials.Prepare contract application and internal budgets for contracts administration.Provide cost-benefit analysis of budgetary considerations and resource utilization issues.Monitor project budgets and allocation of project resources.Develop and lead improvements in team functioning to maximize research progress.Assist with orientation of less senior research staff in protocol and clinical research information.Comply with Good Clinical Practices and departmental research policies and instruct staff in these guidelines and policies.Participate in all mandatory meetings to develop increasing knowledge of assigned research, clinical operations and clinical trials.Complete minimum requirement for continuing educational units.Perform all other duties as assigned.
Minimum QualificationsBachelor's degree in related discipline.Five years related experience, including demonstrated supervisory or lead responsibilities.Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred QualificationsMaster's Degree in related discipline.Experience contributing to peer-reviewed publications.Knowledge of RedCap, EPIC, Microsoft Suite, Good Clinical Practices, Good Laboratory Practices, and OnCore.Classified Title: Research Program ManagerJob Posting Title (Working Title): Clinical Trials Project ManagerRole/Level/Range: ACRP/04/MDStarting Salary Range: $55,800 - $97,600 Annually (Commensurate with experience)Employee group: Full TimeSchedule: M-F 8:30-5Exempt Status: ExemptLocation: School of Medicine CampusDepartment name: SOM Neuro NeuroimmunologyPersonnel area: School of Medicine
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Clinical Trials Project Manager (CTPM)
to join the research team in the division of Neuroimmunology. The Manager will utilize their clinical trials background to liaise, communicate, and perform duties in support of the PI and their multicenter clinical trial. As a senior member of the team, you will work alongside the clinical research team and the PI in the conduct and execution of clinical research projects. Will manage research trials for the clinical research program. The CTPM will maintain a good working knowledge of assigned protocols and projects and their reporting requirements. The position reports directly to the Principal Investigator.Specific Duties & ResponsibilitiesOversee all aspects of start-up and conduct of an investigator-initiated multi-center clinical trial.Participate in investigator meetings, site development and start up meetings with sponsoring agencies.Clarify concerns and questions about new protocols in collaboration with PI and other sites.Participate on conference calls with other participating sites regarding status of clinical trials and site selection meetings.Work with PIs in defining information and plans required to accomplish goals of studies.Ensure smooth implementation of new trials from initial contact through study activation.Serve as central resource for clinical trials group, including the development of guidelines/templates for protocol development to ensure that all regulations are followed in both the development and implementation of clinical trials.Collaborate in the development of consent forms and preparation of regulatory documents.Design and create protocol specific case report forms and assist less experienced staff in design and creation of forms.Prepare and submit multi-pronged internal and external advertisement and participant recruitment plan which may include radio, local health events, partnership with local associations pertaining to disease category and publications and/or web sites.Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to clinical trials.Track each submission through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement system to decrease delays in the trial approvals, and intervene as required to facilitate approval process.Design and compile training materials which aid physicians and staff in complying with protocol requirements.Develop and maintain a protocol database and/or spreadsheets for tracking patient activity, data collection, and financial management.Collect, monitor, organize and maintain all clinical research data.Ensure data accuracy and validity for complex and detailed clinical trials in adherence to all protocol requirements.Ensure timeliness of data so that information may be used by physicians in treatment planning for individual patients, and by the PI for grant writing, presentations and publication.Participate in data analysis.Train and provide oversight of research data management and regulatory issues within the research program.Maintain regulatory binders for assigned protocols.Prepare IRB submissions, initiate and supervise study regulatory files.Function as a liaison with the IRB and Clinical Research Office and other research administration offices.Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and sponsor requirements.Plan and prepare for regular monitoring visits.Prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits.Collaborate with JHU based staff, investigators, regulatory bodies, and sponsoring organizations to resolve study-related needs.Meet with department financial management and understand invoicing for laboratory tests and protocol events defined in the financial contract.Participate in the development of invoicing schedules.Research cost of medical procedures for clinical trials.Prepare contract application and internal budgets for contracts administration.Provide cost-benefit analysis of budgetary considerations and resource utilization issues.Monitor project budgets and allocation of project resources.Develop and lead improvements in team functioning to maximize research progress.Assist with orientation of less senior research staff in protocol and clinical research information.Comply with Good Clinical Practices and departmental research policies and instruct staff in these guidelines and policies.Participate in all mandatory meetings to develop increasing knowledge of assigned research, clinical operations and clinical trials.Complete minimum requirement for continuing educational units.Perform all other duties as assigned.
Minimum QualificationsBachelor's degree in related discipline.Five years related experience, including demonstrated supervisory or lead responsibilities.Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred QualificationsMaster's Degree in related discipline.Experience contributing to peer-reviewed publications.Knowledge of RedCap, EPIC, Microsoft Suite, Good Clinical Practices, Good Laboratory Practices, and OnCore.Classified Title: Research Program ManagerJob Posting Title (Working Title): Clinical Trials Project ManagerRole/Level/Range: ACRP/04/MDStarting Salary Range: $55,800 - $97,600 Annually (Commensurate with experience)Employee group: Full TimeSchedule: M-F 8:30-5Exempt Status: ExemptLocation: School of Medicine CampusDepartment name: SOM Neuro NeuroimmunologyPersonnel area: School of Medicine
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