Teleflex

www.teleflex.com

1 Job

9,556 Employees

About the Company

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. At Teleflex, we are empowering the future of healthcare. Headquartered in Wayne, PA, Teleflex employs over 14,000 people worldwide and serves healthcare providers in more than 150 countries.

Listed Jobs

Company Name: Teleflex
Job Title: Clinical Research Associate
Job Description: **Job Title:** Clinical Research Associate **Role Summary:** Conduct on-site and remote monitoring visits for clinical trials in compliance with regulatory standards (MDR, ISO 14155, ICH/GCP). Ensure data accuracy, subject safety, and adherence to protocols. Collaborate with research teams, provide training and problem-solving strategies, and escalate issues to management. **Expectations:** Execute monitoring activities within timelines, maintain compliance across all study phases, complete thorough documentation, manage safety reporting, and support training initiatives for clinical staff and colleagues. **Key Responsibilities:** - Conduct monitoring visits (site qualification, initiation, routine, closure) to verify protocol adherence, data integrity, and regulatory compliance. - Prepare for visits by organizing timelines, reviewing documentation, and communicating with site staff. - Review medical records, device storage (if applicable), and regulatory documents to assess study performance. - Complete investigator files, monitoring visit reports, and action items with clear resolution steps. - Serve as a liaison for safety reporting to local and national regulatory bodies (EC/NCA). - Collect local safety and data protection requirements, and assist with submissions. - Provide retraining, mentorship, and protocol guidance to clinical site staff. - Oversee training of new clinical staff and lead co-monitoring to ensure compliance. - Support audits, inspections, and in-house reviews (e.g., audits, investigator meetings). **Required Skills:** - Expertise in regulatory standards (MDR, ISO 14155, ICH/GCP). - Strong analytical and problem-solving skills for data accuracy and issue resolution. - Excellent communication and interpersonal abilities to collaborate with investigators, teams, and regulatory contacts. - Proficiency in documentation, report writing, and time management for multi-tasking. - Familiarity with safety event reporting and regulatory submission processes. **Required Education:** Bachelor’s degree in life sciences, healthcare, or related field. **Required Certifications:** 2+ years’ experience as a clinical trial monitor; GCP/ICH (ICH/GCP) certification or equivalent regulatory training.