The Department of Epidemiology is seeking a Research Program Manager who will work under the direction of and in collaboration with the Principal Investigator(s) and other leadership as well as wil 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 JH-CERSI is available here: https://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-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 bi-annual 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
Conduct staff and interviewer meetings to keep staff informed on operations as well as retraining of study procedures.
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.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline.
5 years related experience.
Demonstrated supervisory or lead responsibilities.
Master's Degree in Public Health or similar field (epidemiology, public policy) preferred.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
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.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
Classified Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495 - $72,210 annually (commensurate with experience) Employee group: Full Time Schedule: Monday-Friday 8:30 a.m. - 5:00 p.m. Exempt Status: Exempt Location: School of Public Health Department name: Epidemiology Personnel area: School of Public Health
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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