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

• 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

• 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

• 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

• 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.

• 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

• 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).