The Department of Neurosurgery is 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, the Clinical Research Manager will 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 the 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.
Hybrid/School of Medicine Campus Department name: NUS Pain Institute Personnel area: School of MedicineEqual Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.