Teleflex · 1 day ago
Regional Clinical Research Associate (REMOTE)
United States
Full-time
Remote
Mid, Senior Level
$105K/yr - $115K/yr
5+ years expTeleflex is a global provider of medical technologies, dedicated to improving health and quality of life. The Regional Clinical Research Associate will conduct on-site and remote monitoring visits for clinical studies, ensuring compliance with regulatory standards and addressing any discrepancies or compliance concerns.
CommercialHealth CareMedicalMedical Device
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
Qualification
Required
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
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
Preferred
Vascular Interventional Cardiology is strongly preferred
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
Company
Teleflex
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO
Leadership Team
Liam Kelly
Chairman, President and CEO
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
Recent News
GlobeNewswire
2026-01-09
2026-01-09
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