Clinical Research Manager; Neurology

Benefits

Qualifications

• •Bachelor's Degree in a related field
• •Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment
• •Demonstrated supervisory or lead responsibilities
• •Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula
• •Technical Skills & Expected Level Of Proficiency
• •Budget Management - Advanced
• •Clinical Study Design - Advanced
• •Good Clinical Practices - Advanced
• •Interpersonal Skills - Advanced
• •Oral and Written Communications - Advanced
• •Project Management - Advanced
• •Record Keeping - Advanced
• •Regulatory Compliance - Advanced
• •Strategic Planning - Advanced
• •The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs
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Responsibilities

• •The Clinical Research Manager works under the general supervision of a PI(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites
• •As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies
• •Has accountability for grant submission and administration and regulatory compliance
• •Supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites
• •Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the PI
• •Participate in scientific discussions with collaborators, PI's, and funding organizations
• •Collaborate with PI to ensure operational feasibility of proposed protocol/study design
• •Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s)
• •Develop or oversee the development of consent form(s) for clinical trials based on protocol(s)
• •Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the PI
• •Train and provide oversight of research data management and regulatory issues
• •Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services
• •Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget
• •Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in place to ensure the PRA is followed when required
• •Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing
• •Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials
• •Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data
• •Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial
• •Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies
• •Contribute to presentations and manuscripts
• •Hire, supervise and manage performance of other exempt-level research staff
• •Other duties as assigned
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