CO Sr. Research Program Manager - Johns Hopkins University - Baltimore, MD
Status: Full Time
School: School of Medicine
Location: Mount Washington Campus
full-time position with Emergency Medicine; 37.5 hours per week; Monday – Friday; position requires candidate to meet a flexible schedule, with the ability to work some nights and weekends per study requirements meet short deadlines
In concert with PI, direct the administrative and scientific implementation of multiple active clinical, laboratory and translation components of complex research protocols including multi-site clinical trials. Responsible for development, production and distribution of operating procedures, data collection instruments, databases, study materials, correspondences and reports. Support existing clinical research protocols within Emergency Medicine, as well as, coordinate preparation and submission of new grants to a variety of sponsors including federal and state agencies and private industry. Will have overall managerial responsibilities for exempt level research staff including program managers and research coordinators within Department of Emergency Medicine. Jointly with PI, oversee department’s research studies that cover various PIs and studies.
In collaboration with PI and sponsors, participate in development of study design and standard operating procedures. Responsible for project development and management, coordination of research and implementation teams, preparation of research and other grant reports. Draft and prepare annual and quarterly program reports and work plans. Serve as a liaison with other Johns Hopkins institutions, regulatory bodies, and external funders and partners. Oversee and develop operations manuals for departmental study implementation and maintenance. Develop, prepare and submit grant and contract proposals. Prepare project process reports for funding agencies. Oversee/supervise but, also, work collaboratively with 15-25 research coordinators, research assistants and PhD students and 1 program manager. Promote and ensure good clinical practice, ensuring adherence to clinical research protocols. Interact daily with investigators, collaborators, and technologists to facilitate a smooth flow for study procedures, and activities. Serve as a liaison with outside collaborators to ensure appropriate implementation of study protocols. Report on protocol progress. Using sound judgment, and in a timely fashion, communicate to PI and other investigators problems that may require additional attention and/ or procedure changes to protocols. Act as main coordinator for pharmaceutical companies and for NIH collaborators. Provide oversight of budget expenditures and assist with tracking of project expenditures. Oversee and ensure compliance of clinical treatment studies with FDA regulations. Develop and implement systems for monitoring, reporting, and quality assurance activities. Ensure program quality, research fidelity, and adherence to project goals and timelines. Ensure compliance with HIPAA regulations regarding participant privacy and regulations surrounding the conduct of human subject research. Train new staff members and serve as a content expert resource. Provide oversight and guidance to more junior staff. Perform statistical analysis for reports, manuscripts, and quality assurance reports. Prepare manuscripts for publication at the level of a first or second author. Demonstrate mastery of electronic manuscript submission to academic journals.
Prepare and submit IRB documents for new and renewing protocols. Track amendments and other related documents. Work with PI and select faculty on protocol development and regulatory document preparation. Prepare grant proposals, study progress reports, and manuscripts. Recruit and screen eligible Emergency Department patients for clinical protocols studying current medical treatment technologies. Ensure appropriate informed consent is obtained from subjects. Serve as the main contact for study participants. Operationalize study protocols for execution based on the most efficient methodology. Routinely review and update as needed. Independently problem solve administrative or operational issues related to study execution. Perform data analysis. Participate in the analysis and interpretation of clinical study data. Perform statistical analysis for reports, manuscripts and quality assurance. Provide in-service education and training for ED faculty, residents and nursing staff concerning study rational and conduct. Design and implement advertisements for research study recruitment. Prepare and maintain subject binders, prepare study timelines, and maintain subject databases. Complete case report forms, and/or ensure accurate completion of source documents. Maintain study data, meeting collaborator and sponsor deadlines. Prepare for site monitoring visits.
Perform other duties as required.
Master's degree or PhD in related discipline. Eight years related experience including significant experience in field conducting large research projects. Must be able to balance coordinating both NIH and pharmaceutical company funded projects, as well as, work on projects for collaborators within Emergency Medicine and from other JHU departments and external institutions. Must be able to multi-task and coordinate, as well as, work as a member of a research team that includes faculty, residents, fellows and PhD scholars in the Department of Emergency Medicine. Must have strong interpersonal, management and organizational skills. Experience managing projects and relationships with multiple stakeholders. Demonstrated program management experience, along with strong fiscal and protocol management skills. Demonstrated Supervisory or lead responsibilities. Experience working with human subjects. Experience in health science research, data management and analysis. Experience in grant reporting and research writing. Excellent communication skills necessary along with demonstrated self-management. Sound decision making skills and excellent problem solving skills. Must be autonomous, with a high level of independence. Must be able to supervise subordinate staff members.
**JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.**
NOTE: The successful candidate(s) for this position will be subject to a pre-employment background check.
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