The Center for Immunization Research (CIR) mission is to facilitate the development of new vaccines for infectious diseases of global importance. The CIR is seeking a Research Data Manager to assist with data management activities of vaccine trials. The CIR is committed to the local and global expansion of research activities in the areas of vaccine development, evaluation, policy, and community education. Study teams within the Center are dedicated to the safe and ethical conduct of phase I, II, and III clinical vaccine trials in three main categories: pediatric studies, vaccines to prevent mosquito-borne infections and mucosal and vaccine challenge studies. The CIR partners with many sponsors, including the National Institutes of Health, Department of Defense, and private industry companies. We conduct both outpatient and inpatient clinical trials at our facilities located on the JHU East Baltimore Campus, Johns Hopkins Bayview Campus as well as off-site at private practices in Laurel, Dundalk, Columbia and White Marsh.
Under the direction of the Principal Investigator and Program Director, the incumbent will be responsible for participating in the planning and execution of all data management activities that support the overall work of and research studies within the Center.
Specific Duties & Responsibilities
Create (design, build, and test) electronic data capture (REDCap) databases for studies within the Center.
Validate and maintain databases for FDA Part 11 compliance.
Create recruitment and participant tracking databases and reports in REDCap.
Manage and update study databases prospectively.
Write reports and queries for data validation, cleaning and quality assurance in REDCap.
Create and maintain data dictionaries for datasets.
Import electronic medical record extracted from various sources and perform data cleaning using R.
Train study personnel on performing data entry and running reports using REDCap and maintain documentation.
Provide weekly/monthly updates to study teams on recruitment, study follow-up and other metrics of quality control.
Develop standard analytical summary data files, produce descriptive reports, including tables and graphs.
Develop and oversee standard operating and quality control procedures for data collection/analysis.
Follow best practices for data management and maintaining data in a secure environment.
Work collaboratively with data analysts/study coordinators/staff.
Other duties as assigned.
Bachelor's Degree in related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Proficiency in REDCap and at least one statistical software, R preferred.
REDCap, Microsoft Office, and R.
Must be able to work with inter-related databases.
Must be organized and detail oriented.
Must have excellent inter-personal communication and writing skills.
Experience in longitudinal data management desired.
Experience in vaccine research a plus.
Must be able to work independently after some guidance.
Ability to work on multiple tasks, short deadlines.
Experience in database validation.
Classified Title: Research Data Manager Role/Level/Range: ACRP/04/MC Starting Salary Range: $46,560 - $64,100 (Commensurate with experience) Employee group: Full Time Schedule: Mon. - Fri, 8:30 am - 5:00 pm Exempt Status: Exempt Location: Flexible/School of Public Health Department name: Ctr for Immnztn Rsch Vaccine Scis CIR Personnel area: School of Public Health
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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.
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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