Description of work: The Clinical Research Associate is responsible for Performing clinical monitoring and site management activities to ensure compliance with Catawba Research, LLC and/or the Sponsor’s SOPs as well as Good Clinical Practices (GCPs), ICH guidelines and FDA regulations; Ensure subject safety and timely delivery of project milestones; Provide timely monitoring reports in accordance with the Clinical Monitoring and Site Management Plan for assigned trials; Manage time, monthly calendar, expenses and all deadlines per Catawba Research’s policies and procedures; Perform schedule data reviews per monitoring plans; assist with site selection activities as needed.
Minimum education level: This position requires a 4-year Bachelor’s Degree with preference in a science related field or nursing field, at minimum a Registered Nursing Degree.
Minimum number of years of work experience: Minimum of 2 years of clinical research experience is required.
Training program: Upon initial employment, each team member is required to be trained on Standard Operating Procedures, electronic data capture, HIPAA, time and travel policies, and other internal procedures. All team members receive supplemental and refresher training annually.
Travel expectation: 50% – 75% travel. Domestic and international.
Hours of training required: 20-40 upon initial employment.
EOE: The above description is intended to describe the general nature of the job may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.