About the position 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 (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular intervention or other therapeutic areas.

Responsibilities

• Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable.
• Responsible for all monitoring activities for assigned clinical studies, including: Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex procedures.
• Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report.
• Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate.
• Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance.
• Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution.
• Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation.
• 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 per Teleflex procedures.
• Assists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etc.
• Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities.

Requirements

• 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.
• 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 specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials.
• 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, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently.
• Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management.
• Ability to interact constructively in communication of adherence to protocol and regulatory requirements.
• Responsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipment.

Benefits

• medical
• prescription drug
• dental
• vision insurance
• flexible spending accounts
• 401(k) savings plan
• PTO
• short- and long-term disability
• parental leave