Clinical Trials Project Manager

$55,800 - $97,600/Yr

Johns Hopkins - Baltimore, MD

Full-time - Mid Level

Baltimore, MD

Educational Services

About the position

The Clinical Trials Project Manager (CTPM) will oversee and manage multicenter clinical trials within the Department of Neurology, specifically in the division of Neuroimmunology. This senior role involves collaborating with the Principal Investigator (PI) and the clinical research team to ensure the successful execution of clinical research projects, maintaining compliance with protocols, and facilitating communication among various stakeholders.

Responsibilities

• Oversee 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
• 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
• Initiate and 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
• 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
• Ensure timeliness of data for treatment planning and grant writing
• Participate in data analysis
• Train and provide oversight of research data management and regulatory issues
• 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
• Prepare and submit annual renewal requests, amendments and adverse event reports
• 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
• Meet with department financial management and understand invoicing for laboratory tests and protocol events
• 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
• 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.

Requirements

• Bachelor'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

Nice-to-haves

• Master'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

Benefits

• Total rewards package supporting health, life, career, and retirement