We are seeking a Research Program Coordinator. The Research Program Coordinator is responsible for coordinating clinical research activities for the Glomerular disease clinic in the Division of Nephrology. 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. Experience in phlebotomy preferred.
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 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.
Regulatory Compliance
Responsible for Institutional Review Board (IRB) submissions, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements and sponsor requirements.
Maintain regulatory binders per protocols.
Document adverse events and protocol deviations.
Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
Data Management
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.
Scholarly Activities
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 monitoring and audits of studies including follow-up items. Write responses to audit reports with input from the Principal Investigator.
Conduct periodic audits under the direction of the Program Coordinator and/or PI.
Financial Management
Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials.
Meet with department 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 the development of invoicing schedules.
Prepare and submit invoices to sponsors in a timely manner.
Work with Divisional finance staff to ensure that all invoice amounts are collected and reconciled periodically.
Perform all other duties as assigned.
The Research Program Coordinator is responsible for coordinating clinical research activities for the Glomerular disease clinic in the Division of Nephrology. 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. Experience in phlebotomy preferred.
Perform all other duties as assigned.
Special Knowledge, Skills & Abilities
Excellent organizational skills. Excellent attention to detail. Ability to manage multiple and competing priorities. Excellent time management skills. Excellent oral and written communication skills. 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.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Minimum Qualifications
Bachelor's Degree in related discipline.
Proficiency in the use of common software applications, databases, spreadsheets, and word processing required.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Minimum of one year experience working and interacting with patients.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: 34,842 47,840 60,944 Salary (Commensurate with experience) Employee group: Full Time Schedule: Varies, 8:30 - 5pm Exempt Status: Non-Exempt Location: Johns Hopkins Bayview Department name: SOM DOM Nephrology 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.
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.
Equal Opportunity Employer
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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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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