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 through review of 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, suggest 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 should have a minimum of 5 years of work experience as a clinical trial monitor. The role also involves assisting the Management Team with training needs and developing input on monitoring tools and procedures.
CULTURE :
Customer Experience – Representing Teleflex in a customer-facing position is a significant responsibility and opportunity.
All CMA colleagues are expected to perform with professionalism, service, and ethics to strengthen the Teleflex brand and customer relationships.
Continuous Improvement - Demonstrates initiative and critical thinking to identify and address process and performance gaps, developing solutions for improvement.
Culture and Values – Embodies Teleflex values, ensuring a fair, open, and ethical work environment. Works effectively across boundaries within a complex matrix environment. Leads and participates in the development 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. Coordinate with Research Coordinators and Investigators to schedule and conduct various monitoring visits.
3. Evaluate site practices for quality and integrity, escalating issues as appropriate.
4. Collaborate with the Clinical Studies project team to prepare for visits, escalate findings, and provide input on site performance.
5. Prepare thoroughly for monitoring visits, including email communication 1-2 weeks prior, and optimize on-site time through effective planning.
6. Perform monitoring visits following SOPs, WIs, and regulatory guidelines, applying MDR, ISO 14155, ICH / GCP standards.
7. Complete Investigator Files with all necessary documentation before, during, and after the study.
8. Present findings clearly to site staff, offer retraining, and review data queries to ensure resolution.
9. Serve as a resource between visits for site staff regarding data and visit preparation.
10. Draft accurate Monitoring Visit Reports (MVRs) and follow-up letters per procedures.
11. Document actions professionally, clearly identifying issues and resolutions.
12. Gather and file necessary documents, ensuring compliance with safety reporting requirements.
13. Report safety information to Safety Officers at predefined times and prepare submission documents for EC/NCA as needed.
14. Follow up on safety/adverse event tasks with study sites as requested.
15. Ensure local safety and data protection requirements are met and reported appropriately.
16. Assist the Clinical Project Manager in departmental and study-related activities, including audits, meetings, and training.
17. Conduct co-monitoring to ensure consistency with protocols and standards.
18. Oversee training of new personnel and provide leadership within the RCRA Group.
19. Support regulatory inspections and audits with preparation and documentation.
20. Train site staff on protocol, GCP, data entry, and regulations, providing ongoing mentorship.
21. Perform remote monitoring as per plans and department needs, ensuring timely resolution of queries.
22. Coordinate with Medical Affairs, Sales, and administrative staff to achieve objectives.
23. Adhere to travel policies, submit accurate expense reports, and assist with data management and study documents.
EDUCATION / EXPERIENCE REQUIREMENTS :
* Bachelor’s or higher degree in life sciences, nursing, or related fields, or comparable qualification.
* Knowledge of the medical device sector.
* At least 5 years’ experience in on-site clinical trial monitoring within the medical device or pharmaceutical industry, or CRO.
* Strong attention to detail, organizational skills, and excellent people skills.
* Proven clinical trial monitoring expertise.
* Experience in Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.
SPECIALIZED SKILLS & OTHER REQUIREMENTS :
* Deep understanding of MDR, ISO 14155, ICH / GCP guidelines, with a focus on compliance.
* Aptitude to learn and apply knowledge in relevant therapeutic areas.
* Ability to train and mentor personnel for remote and on-site monitoring.
* Skills to train site staff on protocols, GCP, data entry, and regulations.
* Ability to maintain composure, adapt to shifting priorities, and manage competing demands.
* 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.
* Strong communication skills, both written and oral.
* Ability to work independently and collaboratively.
* Dedicated home office setup to support work responsibilities.
* Fluent in Italian and English, both written and spoken.
* Willingness to travel internationally as necessary.
TRAVEL REQUIRED : Up to 70%.
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