Job Description
Description
Nura is currently hiring a
Clinical Research Coordinator
! The purpose of this position is to perform the day-to-day activities in support of conducting clinical research at the direction of the Principle Investigator. Provide support to the research team to facilitate the achievement of the program’s goals to ensure: clinical trial participant safety and wellbeing, quality data collection; and compliance to research protocols and all applicable regulations and guidelines.
Essential Functions:
Coordinate research protocols including arranging necessary research related appointments and procedures, working collaboratively with research team members, other departments, institutions, and sponsors; and maintain contact with study coordinators at other sites or companies, as well as sponsor personnel.
Screen, recruit, obtain consent from, and enroll research program participants; conduct all research study visits as required by the study protocol.
Collect study data; Complete case report forms in the EDC; Collect information about medical events and monitor them through the study in coordination with the Principle Investigator.
Assist research team with sponsor monitoring visits and internal, routine quality control checks.
Conduct or coordinate training for clinical staff who will be supporting research trials as delegated by the Principle Investigator.
Possess solid understanding of all applicable federal and state regulations concerning human subject research, as well as drug and/or device trials.
Identify problems or obstacles in the system/procedures related to implementation of research protocols and communicate them to the study investigators and research team.
Ensure compliance with all relevant IRB and other regulatory agency requirements.
Collaborate on the development of research study and program materials including, Informed Consent Forms, educational materials, marketing materials, websites, forms, procedures and reports; Obtain IRB approval for these materials as required.
Assist in the preparation and submission of IRB documents and reports, as well as filing and maintaining IRB documentation.
Work with other Research Coordinators and the Principle Investigator to develop, implement, and maintain comprehensive trial master files and research department documentation.
Maintain study timelines including tracking deadlines for research trials and projects.
Coordinate with finance and billing to ensure appropriate billing and payment processes.
Performs other duties as assigned to support the mission, values, and strategies of Nura.
Requirements
Knowledge, Experience & Qualifications:
Technical degree in the clinical field plus 4 years experience or Bachelor’s Degree in a relevant field, RN highly desirable.
Minimum 1-2 years of experience in clinical research preferred.
Excellent communication skills, both written and verbal.
Proficient with computer applications and software to include Microsoft Office Suite
Experience within a medical or educational environment preferred.
Prior work within clinical research or patient care preferred.
Licenses & Certifications:
Clinical Research Coordinator Certification (CCRC) or Certified Clinical Research Professional (CCRP), preferred.
A valid driver’s license and proof of insurance required.
Job Tags
Currently hiring, Work at office