The Department of Emergency Medicine is seeking a Research Program Manager that will be working In concert with the PI and Sr. Research Program Manager. This role will direct the administrative and scientific implementation of multiple research protocols. Must be able to balance coordinating both government and pharmaceutical company funded projects, as well as work on projects for collaborators within Emergency Medicine, and from other JHU departments and external institutions. Will support existing clinical research protocols within Emergency Medicine as well as coordinate the preparation and submission of new grants to a variety of sponsors including federal and state agencies and private industry. Must have strong interpersonal and organizational skills. Must be able to multi-task and coordinate, as well as work as a member of a research team that includes faculty, residents, and fellows in the Department of Emergency Medicine.
In collaboration with management and sponsors, participate in the development of study design and standard operating procedures.
Develop, prepare, and submit grant and contract proposals. Prepare project progress reports for funding agencies.
Recruits, trains, supervises, and evaluates the performance of research assistants and coordinators.
Provide oversight and guidance to more junior staff
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, communicates to the PI and other investigators any problems that may require additional attention and/ or procedure changes to protocols.
Act as the main coordinator for sponsored projects.
Provide oversight of budget expenditures and assist with tracking of project expenditures.
Oversee and ensure compliance of clinical treatment studies with FDA regulations.
Screen and recruit eligible Emergency Department patients for clinical protocols.
Oversees compliance within the regulatory (IRB and federal) framework. Responsible for the integrity of research subject and regulatory binders. Prepare and submit IRB documents for new and renewing protocols. Track amendments and other related documents. Develop and implement systems for monitoring, reporting, and quality assurance. 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.
Represent the protocols in interactions with sponsors and CROs in site qualification, site initiation, site monitoring, and closeout visits, ensuring compliance and providing timely responses.
Perform basic statistical analysis for reports, manuscripts, and quality assurance reports.
This position requires the candidate to meet a flexible schedule, with the ability to work some nights and weekends per study requirements. This position will split time between the Mt. Washington and East Baltimore campuses.
Bachelor's degree in related discipline required. Five years of related experience required. Demonstrated history of supervisory or lead responsibilities. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. 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.
Master's degree in public health, nursing, epidemiology or other health related field desired.
Classified title: Research Program Manager
Department: Emergency Medicine
Work Schedule/Hours: Monday-Friday/8:30-5p/37.5 hrs.
Location: East Baltimore Campus/Mt. Washington Campus
Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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