Clinical Research Manager (DOM Bay Rheumatology)

Job Overview Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Clinical Research Manager to work under the general supervision of one or more Principal Investigators 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 candidate will collaborate with faculty, develop protocols and SOPs, and supervise study-related activities for one or more studies. The role includes accountability for grant submission and administration, regulatory compliance, and oversight of staff at local or multi‑center sites. Responsibilities Partner with investigators and exercise independent judgment in managing the conduct of the research on behalf of the PI. Participate in scientific discussions with collaborators, PIs, and funding organizations. Collaborate with the PI to ensure operational feasibility of the proposed protocol/study design. Develop or oversee the development of standard operating procedures and data collection forms. Oversee the development of consent forms for clinical trials based on protocols. Prepare and submit documentation to the 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 sponsors to determine appropriate patient populations, available resources, and costs for providing services. Collaborate with the finance team to develop study budgets and ensure all costs are included. Ensure the clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and that processes/systems are in place to follow the PRA when required. Track and report clinical research milestones for financial invoicing. Monitor activities, systems, and processes to increase referrals and accruals to clinical trials. Develop, test, and evaluate manuals, questionnaires, and coding structures for efficient data collection. Oversee data collection at a single or multiple sites of a multi‑centered clinical trial. Lead study meetings to examine data, determine next steps, implement changes to protocol operations, and initiate sub‑studies. Contribute to presentations and manuscripts. Hire, supervise, and manage the performance of other exempt‑level research staff. Perform other duties as assigned. Minumum 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, to the extent permitted by the JHU equivalency formula. Preferred Qualifications Master's Degree in a related field. Certification as a Clinical Research Professional. 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. Equal Opportunity Employer Job Postings are updated daily and remain online until filled. EEO is the Law Learn more: Important legal information: #J-18808-Ljbffr The Chronicle Of Higher Education, Inc.