We are seeking a Research Program Coordinator who will have duties and responsibilities related to Radiology patient care in a clinical and Research environment. They will be responsible for coordinating clinical research activities for nuclear medicine physicians and partnering principal investigators and co-investigators within the division, with facets of research activities,
Specific Duties & Responsibilities
Works with study Principal Investigators (PI) and serves as a liaison between multiple collaborators and disciplines to coordinate and supervise the day-to-day clinical research operations and data abstraction.
Responsible for coordination of services and communication of pertinent information to all study participants.
Monitors the clinical course of patients enrolled in clinical trials and ensures that research protocols are executed appropriately.
Prepares for and participates in monthly monitoring visits and audits per sponsor study.
Assists PI with informed consent and implements research protocols through recruiting and enrolling eligible patients into studies.
Prepares relevant documents for Institutional Review Board.
Assiststhe PI in overseeing and maintaining institutional and federal regulatory compliance, including preparing the IRB initial application, annual IRB continuing reviews, changes in research, protocol amendments, annual reports and events reports according to IRB requirements,and facilitates IRB audits.
Submits IND safety reports as needed to the IRB.
Collects research data and manage study databases as required by study protocols; enter data, control data quality and maintain research & data integrity.
Prepares & presents data and project progress to investigators, funding agencies, and necessary compliance authorities as requested/required by protocols.
Detects and assists in solving logistical & technical problems and the development and testing of research protocols.
Ensures PI and co investigators have current and relevant licensure and training.
Assists the administrator in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms.
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies as necessary.
Receive training in different skills such as ECG monitoring etc in order to conduct and complete specific research protocol requirements/ study visit milestones.
Works independently and under the direction of the supervisor to ensure successful completion of each clinical research study.
Dispense correct compensation to research participants for research study visits or milestones reached.
Maintains inventory of study related supplies.
Coordinates the training of other research staff in data management and the use of data collection instruments as necessary.
Develops and maintains organizational and educational tools for staff and subjects to conduct the study accurately and in compliance with good research practice.
Conducts collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations.
Maintains regulatory binders per protocol.
Documents adverse events and protocol deviations.
Involved with 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
Explain protocol procedures to research participants 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.
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 study and follow-up visits
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 as necessitated by particular protocols.
Assist in sample collection, sample delivery or shipment as and when needed by protocol specific procedures/ manual of operations.
Coordinate the collection and documentation of patient information for research purposes.
Maintain a research database of patients enrolled in clinical research.
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 the preparation of data for reports and respond in a timely manner to special projects or queries
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 help facilitate the completion of work with members of the research team regarding data management and the status and Abstract patient clinical and demographic information from a variety of sources and enter into tracking spreadsheet or database.
Meet regularly with Principal Investigators and/ or Research Manager to review data accuracy and overall study progress and status.
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 participate in audits of studies including follow-up items
Conduct periodic audits under the direction of the Research Program Manager and/or PI
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Program Coordinator 03/CD Starting Salary Range: Min $17.00 - Max $30.00 HRLY ($55,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Rad Nuclear Medicine Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
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.
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