Department: Emergency Medicine Work Schedule/Hours: 40 hours per week. *Must be available to work evenings and weekends based on study needs. Research programs in the Emergency Department could run 24-hours a day, 7 days a week between various staff.*
The employee will assume a position in the Department of Emergency Medicine as a Research Program Coordinator conducting various studies sponsored by government agencies or private industry and/or conducting trials which are investigator initiated. The subject population involved in the studies with whom the employee interacts is adults and children who present to the Emergency Department at Johns Hopkins Hospital. The Research Program Coordinator will coordinate the day-to-day logistical and operational tasks of various clinical screening programs/research studies in the Department of Emergency Medicine. S/he will interact with the medical directors, collaborators, clinicians, and patients in a coordination role. This person will be responsible for carrying out program activities in accordance with good clinical practices.
Duties & Responsibilities
Work on multiple clinical studies; Maintain detailed knowledge of all assigned protocols; Adhere to all protocol requirements to ensure the validity of the clinical research data.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements; Perform subject recruitment including interviewing patients, obtaining subject informed consent, and completing study visits to include vital signs and obtaining clinical samples.
Interact with clinicians and other gatekeepers to access the patient population.
Confirm patient registrations and relevant data points in databases.
Maintain a research chart for each patient.
Verify scheduling of patient appointments, tests, and follow-up visits at the appropriate time to assure completion of protocol requirements.
Assist with data entry and data abstraction.
Ensure accuracy and timeliness of data so that information may be used for presentations and publication.
Meet regularly with Sr. Research Program Manager and/or team leader to review data accuracy, shift reports, and overall study progress.
Participate in all mandatory meetings; Schedule meetings as needed/requested; create meeting agendas and meeting minutes; work closely with other research team members.
Prepare mandatory reports and documents/protocols needed to complete regulatory requirements for submission to JHU employees and/or the sponsor.
Prepare for and participate in audits and monitoring of studies.
Respond in a timely manner to special projects or queries related to the projects.
Assist in preparation of IRB protocols and related documents.
Maintain working knowledge of and compliance with Good Clinical Practices, ICH Guidelines, and IRB requirements.
Coordinate schedule/calendar for project staff.
Conduct supply inventory on a regular basis and order supplies, as needed.
Recruit and train new study staff and update training manuals/protocols as needed.
Provide in-service education and training concerning project rationale and conduct.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis; It does not exclude other duties as assigned.
Bachelor's degree in related discipline and some related experience. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.*
Special Knowledge, Skills, or Abilities/Competencies: Must be comfortable collecting saliva, urine, or blood samples from patients. Proficiency in the use of computers, including software applications, databases, spreadsheets, and word processing. Excellent organizational and time management skills. Independent and self-motivated, needing little to no supervision. Highly organized and detail oriented. Ability to manage multiple and competing priorities. Excellent oral and written communication skills. Demonstrated strong, positive interpersonal skills. Ability to communicate effectively across disciplines and within a variety of cultures. Must be available to work evenings and weekends based on study needs. Research programs in the Emergency Department could run 24-hours a day, 7 days a week between various staff.
*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.
A year of related experience in clinical trials/health research preferred.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.