Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards for assigned clinical studies in the field of vascular intervention or other therapeutic areas. • Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety. • Responsible for all monitoring activities for assigned clinical studies, including: • Scheduling and conducting monitoring activities onsite or remote within specified timelines. • Identification of data discrepancies and compliance concerns; present findings to site research staff. • Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits. • Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits. • Presents findings to site staff and provides clear directions for resolution. • Serves as a resource to site staff between monitoring visits. • Trains and mentors Teleflex personnel on monitoring procedures and practices. • Conducts site training and co-monitoring visits as requested by management. • Completes monitoring visit reports, action items, and monitoring visit follow-up letters. • Assists with team, department, and study-related projects as requested. • Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary. Qualifications • Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines. • Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO. Requirements • Demonstrated aptitude and knowledge in relevant therapeutic area; Vascular Interventional Cardiology is strongly preferred. • Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. • Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations. • Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). • Strong knowledge of medical terminology. • Ability to work independently in a regional area with minimal supervision. • Excellent organizational and problem-solving skills. • Excellent interpersonal skills, ability to interface and communicate effectively. • Ability to interact constructively in communication of adherence to protocol and regulatory requirements. • Responsible for adequate and reasonable home office setup. Benefits • Medical, prescription drug, dental and vision insurance. • Flexible spending accounts. • Participation in 401(k) savings plan. • Various paid time off benefits, such as PTO, short- and long-term disability and parental leave. Apply tot his job