Clinical Research Coordinator RN - Clinical Research Center - FT - Day

Position Status:

Full time

Shift:

First Shift (Days - Less than 12 hours per shift) (United States of America)

Hours per week:

40
Job Information
Exemption Status: Exempt

A Brief Overview
The Clinical Research Coordinator is responsible the coordination of clinical research protocols. Activities include, but are not limited to: protocol feasibility, subject recruitment, eligibility assessment, informed consent, study-specific procedures, data collection, case report form maintenance, protocol compliance, drug supply inventory, and interactions with physicians, clinical research associates, patients and others. The Clinical Research Coordinator RN promotes Good Clinical Practice in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations, human subject protections, and other research regulation requirements. The delivery of professional nursing care at Stormont-Vail Health is guided by Jean Watson's Theory of Human Caring and the theory of Shared governance, both of which are congruent with the mission, vision, and values of the organization.

Education Qualifications

• Bachelor's Degree Bachelor's of Science in Nursing (BSN) Preferred
• Associate's Degree Associate's Degree of Nursing Science Required

Experience Qualifications

• Clinical research experience. Preferred

Skills and Abilities

• Establish and maintain working knowledge of the Code of Federal Regulations. (Required proficiency)
• Establish and maintain working knowledge of International Code of Harmonization. (Required proficiency)
• Establish and maintain expert knowledge of SVH/COC Policies. (Required proficiency)
• Establish and maintain expert knowledge of HIPPA guidelines and protect patient/subject personal health information per SVH/COC guidelines. (Required proficiency)
• Establish and maintain expert knowledge of Clinical Research Center Standard Operating Procedures. (Required proficiency)

Licenses and Certifications

• Registered Nurse - KSBN Required
• Basic Life Support - BLS Required within 90 days of hire.
• Certification from an accredited association of clinical research professionals is preferred.

What you will do

• Coordinate the conduct of clinical trials. o Coordinate clinical trials, adhering to the protocol and coordinating the research subject through the protocol requirements and schedule. o Coordinate subject identification and eligibility activities, including database lists, incoming calls and inquiries, telephone screening, chart reviewing, discussing the protocol with prospective subjects, presenting/re-presenting candidates to principal and sub investigators, and scheduling per protocol requirements. o Document subject’s relevant medical history, research source documentation, and Epic documentation per Clinical Research Center Standard Operating Procedures (SOPs). o Conduct informed consent following the Clinical Research Center SOPs and demonstrate an in depth understanding of the protocol and the ICF document. o Manage laboratory requirements of protocol, including requisitions, education of phlebotomy staff, review of results, and coordination with principal and sub investigators per Clinical Research Center SOPs. o Document and address Adverse Events, IND Safety Letters, and Serious Adverse Events per Clinical Research Center SOPs and sponsor requirements. o Manage drug accountability for assigned protocols, complying with the Clinical Research Center SOPs and sponsor requirements. o Maintain protocol regulatory binders, complying with the Clinical Research Center SOPs. o Manage IRB communication, complying with the Clinical Research Center SOP. o Manage monitor visits, including scheduling and follow-up. o Manage protocol amendments per Clinical Research Center SOPs and by using following the Amendment Flow Sheet. o Manage study close-outs activities per sponsor requirements, using the Clinical Research Center Study Close-out Checklist. o Attend protocol-specific and industry meetings as assigned.
• Prepare and administer IV investigational products as specified by research protocols and in compliance with Clinical Research Center SOPs.
• Assist with department tasks and responsibilities: o Assist with study start-up, including: planning, organizing, trouble-shooting, and coordinating activities with SVH/COC departments for needed protocol procedures, such as radiology, ultrasound, respiratory therapy, endoscopy, etc. o Serve as back-up coordinator as assigned. o Assist/comply with quality assurance and process improvement systems per Clinical Research Center SOPs. o Communicate with primary care offices