POSITION SUMMARY :
The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH / GCP guidelines, Teleflex procedures, and IRB / EC policies and procedures). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team, or department needs to evaluate data accuracy and subject safety by reviewing regulatory documents, medical records, reported data, and device storage, if applicable. The Senior CRA must be able to identify issues, present findings to site staff, provide retraining if needed, offer problem-solving strategies, and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. The Senior CRA has a minimum of 5 years of work experience as a clinical trial monitor. The Senior CRA also assists the Management Team with training needs and contributes to developing and providing input on monitoring tools and procedures.
CULTURE :
Customer Experience – Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity.
All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and our relationships with customers.
Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps, developing solutions to improve results. Exhibits continuous improvement of thought processes and focus.
Culture and Values – Embodies Teleflex values, ensuring a fair, open, and productive environment that is engaging, ethical, and legally compliant. Works effectively across boundaries in a complex matrix environment. Leads and participates in the development and review of promotional and other materials, ensuring accuracy and compliance.
PRINCIPAL RESPONSIBILITIES :
1. Conduct monitoring within timelines and according to the monitoring plan and Teleflex procedures.
2. Collaborate with Research Coordinators and Investigators to schedule and conduct monitoring visits, including site qualification, initiation, routine monitoring, and closure visits.
3. Evaluate the quality and integrity of site practices and escalate issues as appropriate.
4. Work with the Clinical Studies project team to prepare for visits, escalate significant findings, and provide input on site performance.
5. Prepare thoroughly for monitoring visits, including sending pre-visit emails 1-2 weeks prior, and maximize on-site time through effective planning.
6. Conduct monitoring visits following SOPs, WIs, monitoring plans, and regulatory standards (MDR, ISO 14155, ICH / GCP, Teleflex SOPs and WIs).
7. Complete Investigator Files with all required documentation, ensuring all is finalized before and during each phase of the study.
8. Present findings to site staff, provide clear resolution directions, and offer retraining when necessary. Review data queries with site staff for understanding and resolution.
9. Serve as a resource to site staff between visits for clarification and insights.
10. Complete Monitoring Visit Reports (MVRs) and follow-up letters professionally, accurately, and succinctly.
11. Document monitoring actions clearly, identifying issues and providing instructions for resolution.
12. Manage document collection and filing appropriately.
13. Ensure compliance with safety reporting requirements, reporting to Safety Officer (SO) as per schedule.
14. Prepare safety documentation for EC/NCA submissions upon request and liaise with authorities regarding safety reports.
15. Follow up on safety/adverse event tasks with study sites as directed by SO.
16. Ensure local safety and data protection requirements are met and documented.
17. Assist the Clinical Project Manager with departmental and study-related tasks such as audits, investigator meetings, and training.
18. Conduct co-monitoring to ensure consistency with protocols, SOPs, WIs, and standards.
19. Oversee training of new Clinical Studies personnel and provide leadership within the RCRA group.
20. Support in adapting WIs and guidelines to comply with regulations.
21. Prepare for and support safety inspections and audits.
22. Train site staff on protocol, GCP, data entry, and regulations, including ongoing training sessions.
23. Perform remote monitoring activities according to plans and study needs.
24. Collaborate with Medical Affairs, Sales, and administrative staff as needed.
25. Comply with Teleflex travel policies, submitting accurate expense reports.
26. Contribute to eCRF completion, data query resolution, and study documentation.
27. Participate in study team meetings, develop conference calls, FAQs, and other documents.
EDUCATION / EXPERIENCE REQUIREMENTS :
* Bachelor’s or higher degree in life sciences, nursing, or related health disciplines, or equivalent qualification.
* Knowledge of the medical device sector.
* At least 5 years of on-site monitoring experience in the medical device or pharmaceutical industry or with a CRO.
* Strong attention to detail, organizational skills, and excellent interpersonal skills.
* Proven clinical trial monitoring skills.
* Experience with Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.
SPECIALIZED SKILLS & OTHER REQUIREMENTS :
* Deep understanding of MDR, ISO 14155, and ICH / GCP guidelines with a strong compliance focus.
* Aptitude for learning and applying new therapeutic area knowledge.
* Ability to train and mentor personnel for remote and on-site monitoring.
* Skill in training site staff on protocols, GCP, and regulations.
* Ability to maintain composure, adapt to shifting priorities, and handle challenging situations.
* High accuracy and attention to detail.
* Experience working independently in regional settings with minimal supervision.
* Proficiency in medical terminology, MS Word, Excel, and database applications.
* Ability to work independently and within a team, with a suitable home office setup.
* Fluent in Italian and English (written and spoken).
* Willingness to travel internationally if necessary.
TRAVEL REQUIRED : Up to 70%.
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