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, suggest problem-solving strategies, and communicate findings to the study team and department management via escalation or monitoring visit reports. The position requires a minimum of 5 years of work experience as a clinical trial monitor. Additionally, the Senior CRA assists the Management Team with training needs and contributes to developing and improving monitoring tools and procedures.
CULTURE :
Customer Experience – Representing Teleflex in a customer-facing role is a significant responsibility and opportunity.
All CMA colleagues are expected to perform with the highest 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. Develops solutions for continuous improvement.
Culture and Values – Embodies Teleflex values, ensuring a fair, open, and productive environment that is engaging, ethical, and compliant. Collaborates effectively across functions to ensure promotional and study materials are accurate and compliant.
PRINCIPAL RESPONSIBILITIES :
1. Conduct monitoring activities within timelines and according to the monitoring plan and Teleflex procedures.
2. Coordinate with Research Coordinators and Investigators for scheduling and conducting various monitoring visits, including site qualification, initiation, routine monitoring, and closure.
3. Evaluate site practices for quality and integrity, escalating issues as necessary.
4. Collaborate with the project team to prepare for monitoring visits, escalate significant findings, and provide input on site performance.
5. Prepare thoroughly for monitoring visits, including sending pre-visit emails and optimizing on-site time.
6. Perform monitoring visits in accordance with SOPs, WIs, and guidelines, ensuring compliance with MDR, ISO 14155, ICH / GCP, and Teleflex standards.
7. Complete Investigator Files with all required documentation before and after visits.
8. Present findings clearly to site staff, providing directions and retraining as needed, and review data queries.
9. Serve as a resource for site staff between visits for clarification and insights.
10. Document monitoring activities and action items professionally and accurately.
11. Ensure compliance with safety reporting requirements, report to Safety Officer, and prepare necessary documentation for EC/NCA submissions.
12. Follow up on safety/adverse event tasks with study sites as requested.
13. Gather local data protection information and report to CPM before study start.
14. Assist in study-related projects, training, audits, and inspections.
15. Conduct co-monitoring to ensure consistency with protocols and standards.
16. Oversee training of new staff and provide leadership within the clinical studies team.
17. Support regulatory inspections and audits.
18. Train site staff on protocol, GCP, and data entry.
19. Perform remote monitoring as per plan and study needs.
20. Interface with Medical Affairs, Sales, and administrative staff as needed.
21. Comply with travel policies, complete expense reports, and support data management tasks.
22. Participate in study team activities, develop study documentation, and assist with FAQs and study materials.
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 clinical trials within the medical device or pharmaceutical industry or CRO.
* Strong attention to detail, organizational skills, and excellent interpersonal skills.
* Proven clinical trial monitoring skills.
* Experience with Vascular Interventional Cardiology or Peripheral Vascular Intervention is advantageous.
SPECIALIZED SKILLS & OTHER REQUIREMENTS :
* Comprehensive knowledge 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 staff for remote and on-site monitoring.
* Skilled in training site staff on protocols, GCP, and regulations.
* Ability to maintain composure and adapt to shifting priorities.
* High attention to detail and accuracy.
* Experience working independently in regional settings with minimal supervision.
* Proficient in medical terminology, and skilled with MS Word and Excel.
* Ability to work independently and as part of a team.
* Responsible for maintaining a suitable home office environment.
* Fluent in Italian and English (written and spoken).
* Willingness to travel internationally if necessary.
TRAVEL REQUIRED : Up to 70%.
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