We are seeking a Research Program Coordinatorwho will be responsible for coordinating clinical research activities for rheumatology and pulmonary physicians operating within the Johns Hopkins Myositis 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 investigators 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 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.
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.
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.
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.
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Related clinical research experience preferred.
Experience in phlebotomy preferred.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.75 - $23.00/hr (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am - 5:00 Pm 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:
JHU Equivalency Formula: 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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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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