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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 across the Precision Medicine Center of Excellence. As a senior member of the team, will work alongside the clinical research team and several PIs in the conduct and execution of clinical research projects. Will manage research trials and registry databases within the clinical research program. The CTPM will maintain a good working knowledge of assigned protocols and projects and their reporting requirements. The position reports to the division’s Sr. Research Program Manager, with an indirect reporting line to the principal investigators.

Specific Duties & Responsibilities

• Oversee all aspects of on-going existing and new industry-sponsored clinical trials and be responsible for a portfolio of multiple industry-initiated clinical trials.

• Participate in sponsor-initiated investigator meetings, site development and start up meetings with sponsoring agencies.

• Clarify concerns and questions about new protocols in collaboration with PI and sponsor.

• Participate on conference calls with sponsor regarding status of clinical trials and site selection meetings.

• Work with PIs and Sr. Research Program Manager (SRPM) 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 and writing of protocols and 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 multiple clinical trials

• Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implements 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.

• Meet regularly with SRPM to review data accuracy and overall compliance progress.

• 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.

• Create Standard Operational Procedures, prepare IRB submissions, initiate and supervise study regulatory files for all trials in the division.

• 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 SRPM to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as 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.

• Train and provide oversight of research data management and regulatory issues within the research program.

• 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 Qualifications

• Bachelor's Degree in related discipline.

• Five years related experience.

• Demonstrated supervisory or lead responsibilities.

• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree in related discipline preferred.

• Experience contributing to peer-reviewed publications.

• Knowledge of RedCap, EPIC, Microsoft Suite, Good Clinical Practices, Good Laboratory Practices, STATA, SAS, OnCore.

Classified Title: Research Program Manager

Job Posting Title (Working Title): Clinical Trials Project Manager

Role/Level/Range: ACRP/04/MD

Starting Salary Range: $55,200 - $96,600 Annually (Commensurate with experience)

Employee group: Full Time

Schedule: M-F 8:30 am - 5:00 pm

Exempt Status: Exempt

Location: School of Medicine Campus

Department name: SOM Neuro Neuroimmunology

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.