Under the direction of and in collaboration with the Principal Investigator(s) and other leadership, we are seeking a Research Program Manager who will be responsible for the day-to-day operations of the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI), a multi-year contract funded by the U.S. Food and Drug Administration (FDA) that facilitates collaborative research between Johns Hopkins faculty and FDA scientists focused on FDA's regulatory science priorities. In this capacity, the candidate will be involved with developing new proposals submitted to the FDA; serving as a key interface between FDA staff and scientists and Johns Hopkins investigators and trainees; and facilitating the administration, monitoring and reporting out of scientific and educational activities undertaken at Johns Hopkins University on behalf of the JH-CERSI. More information about specific duties is provided below and more information about the JHCERSI is available here: https://publichealth.jhu.edu/center-of-excellence-in-regulatoryscience-and-innovation.
The candidate will also support the activities of Johns Hopkins Center for Drug Safety and Effectiveness (CDSE), a nexus of scholarship focused on pharmacoepidemiology and drug
policy at Johns Hopkins, and The Research Program Manager will administratively coordinate protocol design and implementation and work directly with faculty and senior staff to
coordinate, collect, manage and conduct data related activities. The CDSE uses state-of-the-art analysis methods to address timely questions examining medication effectiveness, safety and utilization and the impact of drug policies, in order to improve prescription drug use and pharmaceutical policy in the United States and around the world. Many of the scientific
investigations examine either population-based patterns and determinants of pharmaceutical use or the impact of changes in pharmaceutical policy on pharmaceutical expenditures and
utilization. In this capacity, the Research Program Manager will manage and coordinate as well as aid in the conduct of research and data analysis using secondary data from audits of
office-based prescribing or other national surveys, administrative health claims, information about retail pharmacy sales and pharmaceutical distribution or promotion and electronic health
records. The Research Program Manager will be directly involved in all phases of projects, from conceptual development through implementation, analysis, and the production of papers,
posters, and other academic products. Numerous examples of the types of projects that will be pursued are reflected by Dr. Alexander's work which is available in PubMed.
Specific Duties & Responsibilities
Serve as point of contact between Johns Hopkins faculty and FDA staff for communications related to CERSI research and administrative matters.
Coordinate CERSI quarterly update meetings, including development and iteration of update slides.
Draft, iterate and submit bi-annual FDA and NIH reports detailing CERSI activities and accomplishments.
Administer and provide day-to-day oversight of research award from the U.S. Food and Drug Administration focused on key regulatory science priorities (CERSI)
Manage development, submission, and initiation of FDA-funded collaborative research projects led by Johns Hopkins faculty.
Maintain detailed working knowledge of study protocols and ensure adherence to protocols.
Meet with the research team as needed and facilitate regular communication to provide oversight and guidance in protocol implementation and adherence.
Serve as a preceptor to student volunteers.
Plan and conduct literature reviews; develop data collection instruments; transcribe and code data; prepare summaries and reports.
Conduct descriptive and other statistical analyses for senior analysts and faculty.
Assist in the interpretation of analyses and writing of manuscripts and other reports.
Present research findings at staff meetings, seminars, and scientific conferences; participating in writing reports and manuscripts.
Demonstrate and serve as a role model for a positive work environment, including high motivation, positive attitude, good judgment, tact and sensitivity in all interpersonal interactions with research staff, investigators, students and participants.
Perform other duties as assigned.
Special Knowledge, Skills, & Abilities
The ideal candidate for this position will have excellent verbal and written communication skills, outstanding quantitative skills, and a strong interest in collaborative research.
Data management and organizational skills are important.
Attention to detail.
Strong interpersonal skills and excellent organizational and time management skills required.
Ability to work independently and manage multiple tasks.
Proficiency in Microsoft Word and Excel.
All IRB-required courses must be completed, and appropriate exams passed with necessary certification within 2 weeks of start date.
Minimum Qualifications
Bachelor's Degree in related discipline. Related Master's preferred.
Five years related experience, including demonstrated supervisory or lead responsibilities.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $55,200 - $96,600 Annually Employee group: Full Time Schedule: Monday to Friday: 8:30 am – 5 pm Exempt Status: Exempt Location: School of Public Health Department name: Epidemiology Personnel area: School of Public Health
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 Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.