The Research Program Coordinator is responsible for coordinating clinical research activities for the Vasculitis Center. The Coordinator will oversee all facets of research activities, including patient recruitment and scheduling, data collection and management, specimen collection, handling and processing, compliance with IRB regulations and communicating with team members on the status of projects. The individual will act as primary liaison between principal investigator, School of Medicine, Research Administration, GCRC, funding agencies and other study related organizations.
Specific duties & responsibilities:
Clinical Research Activities
Assist the principal investigator with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies
Explain protocol procedures and obtain informed consent
Schedule patients' appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers.
Be responsible for organization, entry, maintenance and accuracy of patient clinical research data
Design and compile materials which aid physicians and other staff in complying with protocol requirements
Establish study calendar of various clinical protocols including clinical trials and coordinate the logistics needed for successful completion of the studies.
Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols
Collect patient source documents and case report forms for analyzing patient data.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study and ensure integrity of data collected
Coordinate the collection and documentation of patient information for research purposes.
Organize and create clinical research charts to be reviewed by regulatory agencies
Maintain a research database of patients enrolled in clinical trials
Participate in and or organize community events to increase public awareness
Ability to proficiently collect, process and store bio specimen collections
Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements
Maintain regulatory binders per protocols
Document adverse events and protocol deviations
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements
In partnership with divisional research leaders, create and/or maintain research standard operating procedures
Responsible for maintaining and promptly updating online Clinical Research Management System
Assist with preparation of data for reports and presentations
Respond in a timely manner to special projects or queries related to data
Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process
Perform quality checks on data entry
Ensure accuracy and timeliness of data collection. Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies
Abstract patient clinical and demographic from a variety of sources and enter into tracking spreadsheet or data base
Assist with writing manuscripts and abstracts for publication
Assist with development of grants, progress reports and study protocols
Research Program Oversight
Meet regularly with Principal Investigators to review data accuracy and overall study progress
Work with the Center Directors and/or study sponsors on problem recognition/resolution, accuracy of data gathered and patient well-being, completion and collection of regulatory documents required by sponsors
Prepare for and participates in audits of studies including follow-up items
Conduct periodic audits under the direction of the Program Coordinator and/or PI
Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials
Special knowledge, skills, and abilities:
Contribute to the development, management, and safe archiving of research databases, including but not limited to REDCap, OpenSpecimen, and Microsoft Access.
Lead the harmonization of data from multiple sources, including legacy databases, Epic EMR, Open Specimen, and novel data sources (e.g. device, imaging data) into the Johns Hopkins Precision Medicine Analytics Platform (PMAP; SQL computing environment).
Bachelor's degree in related discipline
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
Proficiency in the use of common software applications, databases, spreadsheets, and word processing required.
Excellent organizational skills required.
Excellent attention to detail skills required.
Must have ability to manage multiple and competing priorities.
Must have excellent time management skills.
Must have excellent oral and written communication skills.
Must be able to work independently.
The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and be comfortable being part of a diverse professional team.
Experience in a clinical research setting.
Knowledge of SQL preferred.
Experience in phlebotomy preferred.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: Commensurate with experience Employee group: Full Time Schedule: M-F 8:30am - 5:00pm Exempt Status: Non-Exempt Location: Hybrid/Johns Hopkins Bayview Department name: SOM DOM Bay Rheumatology Personnel area: School of Medicine
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 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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