Clinical Research Manager (DOM Infectious Disease)

We are seeking a Clinical Research Manager who will work 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. Specific Duties & Responsibilities • 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. Minimum 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. Preferred Qualifications • Master's Degree in a related field. • Certification as a Clinical Research Professional. Classified Title: Clinical Research Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $28.61 - $50.05 HRLY ($45,000 targeted; Commensurate w/exp.) Employee group: Part-time Schedule: Mon-Friday 4.5 hours per day flexible FLSA Status: Exempt Location: Remote Department name: SOM DOM Infectious Disease Personnel area: School of Medicine