Under the direct supervision of the Co-Directors of the Rheumatic Diseases Research Core Center and the Director of the Research Management and Patient Integrated Data (RAPID) Core Center the individual is responsible for the collection, organization, entry, maintenance and accuracy of clinical research data for clinical studies. She/he will collaborate in development & writing of consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns & questions about new protocols with PI and/or sponsor. This position will support investigators across the Division of Rheumatology. Studies may include longitudinal observational studies as well as interventional clinical trials of investigational medications, devices, or other lifestyle interventions.
Specific duties & responsibilities:
Complete and maintain up to date documentation of human subjects' research training required by the JHM IRB and protocol Sponsors including and not limited to: JHM Research Compliance, HIPAA, Blood borne Pathogens, and CPR.
Attend and participate in staff and division meetings, protocol and research-related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
Advise and assist multiple Investigators in conceptualizing data collection needs and translating these needs into collected data
Assist with developing plans for subject recruitment; advertising and recruitment materials, flyers, and other advertisements in newspapers, websites, or other venues as determined by study team.
Inform potential study subjects about research studies, procedures, and protocol requirements.
Explain the informed consent process to subjects, obtain, and document subject informed consent.
Conduct screening interviews and administer screening questionnaires.
Perform protocol-specific in-service training for research staff
Oversight of the order and inventory of clinical supplies necessary for performance of studies.
Oversight of the coordination for the subject study visits according to study protocol to include vital signs, ECGs, phlebotomy, and obtaining clinical samples.
Design and compile materials which aid physicians and other staff in complying with protocol requirements for these visits and tests.
Collect, compile, and maintain data in a research chart for each patient from a variety of sources.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Monitor to confirm accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication.
Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about study issues.
Respond in a timely manner to special projects or queries related to the data.
Meet with the Principal Investigator to review data accuracy and overall study progress.
Communicate with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
Participate in relevant protocol, sponsor, and other meetings as required to remain current and increase knowledge of clinical trials.
Be willing and available for travel to research and study-related meetings if deemed necessary by the Principal Investigator.
Be available to work evenings and/or weekends per study requirements (e.g. investigator meetings).
Participate in regular meetings of the Research Management and Patient Integrated Data Core
Provide quarterly reports on Core service utilization to RAPID and RDRCC Administrative Cores
Additional duties may be required that are not yet identified.
Minimum qualifications (mandatory):
Bachelor's Degree in related discipline required.
Experience: Requires minimum of 3 years' experience related to clinical research. Participation as a primary research coordinator in other multicenter studies is highly desirable, as is related experience in Rheumatology or musculoskeletal conditions. Must understand and pass all Johns Hopkins online Human Research Certification courses and training courses in bio-hazardous materials handling.
Special knowledge, skills, and abilities:
Phlebotomy skills preferred. Proficiency in the use of software applications (i.e. Microsoft Access, Excel), databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail required. Must have ability to manage multiple and competing priorities. Must have excellent time management skills; oral and written communication skills and be able to work independently. The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and comfort being part of a diverse professional team.
Technical qualifications or specialized certifications:
Basic Life Support/CPR certification is required within the first 6 months of employment and must be maintained. Additional participation in Johns Hopkins research staff professional development pathways encouraged. Certification within 2 years as CCRP (SoCRA) or CCRC (ACRP) is required and must be maintained. Additional experience as a Research Coordinator and/or in a Medical Assistant role with knowledge of EPIC is required. Per divisional policy, the individual is required to adhere to the clinical research staff professional appearance guidelines which includes wearing a uniform.
Classified title: Sr. Research Program Coordinator
Starting Salary Range: 37,781 - 51,950
Employee group: Full time
Employee subgroup: Exempt
Schedule: Working 37.5 hours per week; Monday-Friday
Location: Johns Hopkins Bayview Medical Campus
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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