What are the responsibilities and job description for the Research Nurse position at Rockford Gastroenterology, Assc., LTD?
Job Description
Job Description
Description :
The Clinical Research Nurse, under the direction of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state and local regulations, Institutional Review Board (IRB) approvals, and policy and procedures. This position also assists with the education and scheduling of patients who have been ordered Video Capsule Endoscopy, esophageal pH testing and neuromodulation therapy for the control of bowel function.
Coordinate and Manage Clinical Studies
Conduct all clinical studies according to FDA regulations and guidelines
Obtain detailed knowledge of all components of study protocol so that all study activities are completed correctly and completely
Screen volunteers to identify potential volunteers for a specific study accurately, on a timely basis, and within the recruitment period
Schedule all volunteer visits and procedures to meet protocol requirements. Provide instructions and dates to volunteers to ensure proper protocol compliance
Validate potential volunteer data against pre-established inclusion criteria to enroll qualified volunteers only
Ensure that all laboratory samples are collected properly and tests are performed accurately and on a timely basis
Distribute study medication according to protocol requirements and maintain accurate and complete distribution records
Notify subjects and physician of all adverse reactions to study medication and identify what is a “serious adverse reaction” versus non-emergent adverse reaction
Report all adverse events to the sponsor and IRB in compliance with FDA regulations and sponsor requirements. Report all serious adverse events to the sponsor and IRB within 24 hours of notification
Prepare materials before each patient visit. Ensure accurate drug and supply distribution for each patient by proper inventory and organization of supplies
Draw blood, obtain specimens and EKG’s from volunteers according to established procedures
Process and package lab specimens for shipment to central labs according to instructions
Keep accurate records of all study-related medication shipments, and distribute study medications according to the protocol requirements and maintain accurate and complete distribution records
All other tasks as assigned by Research Manager
Record keeping and documentation
Provide sponsor with accurate and complete documentation per sponsor requirements.
Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines. Retain and / or forward copies of forms as required by the sponsor
Subject Care
Be a subject advocate and ensure the safety and welfare of all subjects.
Explain to the subject in layman’s terms the purpose and possible benefits of participating in a study to provide complete and accurate study information
Act as a liaison between the study subject and his / her physician concerning any problems, adverse reactions, etc. related to the study medication or study procedures
Ensure that the subject has properly signed the consent form before becoming involved in any aspects of the study as a subject, and give a signed copy of the consent to the subject
Use judgement to analyze appropriate patient data and adverse events that are essential for progress reports to physicians. Effectively report subject data and adverse reactions on a timely basis
Communication
Act as liaison between Investigator, study staff, sponsor representatives, other auditors, and IRB
Work in a collaborative, effective manner with the research team as well as with all sponsor personnel to meet research objectives
Excellent written and communication skills
Requirements : Qualifications
Registered Nurse or Licensed Practical Nurse with equivalent experience
Demonstrated ability to coordinate and establish priorities among diverse tasks
Demonstrated effective organizational and communication skills
After 2 years of full-time employment in the Research Department, an employee becomes eligible to sit for the national Certified Clinical Research Coordinator (CCRC) exam administered by the Association of Clinical Research Professionals (ACRP).
Act as a back during Bravo pH monitoring production
Schedule patients for Bravo pH monitoring, InterStim, and video capsule endoscopies, Duties may include but are not limited to patient education, prep instruction, and assisting with equipment.
Essential Physical Demands :
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Must be able to stand for extended periods of time
Must be able to help lift, turn, roll, push, and pull equipment / patients for proper positioning during procedures and transportation from one area to the other as necessary
Working Conditions :
Exposure to blood borne pathogens requiring the use of universal precautions and / or personal protective equipment.
Knowledgeable of potential exposure to hazardous materials (i.e., patient body fluids and disinfectant chemicals).
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