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. Develops solutions to improve results and exemplifies continuous improvement in thought processes and focus.
Culture and Values – Embodies Teleflex values, ensuring a fair, open, and productive environment that is engaging, ethical, and 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 :
* Conduct monitoring within timelines and according to the monitoring plan and Teleflex procedures.
* Collaborate with Research Coordinators and Investigators to schedule and conduct monitoring visits, including site qualification, initiation, routine monitoring, and closure.
* Evaluate site practices for quality and integrity, escalating issues as appropriate.
* Work with the Clinical Studies project team to prepare for visits, escalate significant findings, and provide input on site performance.
* Prepare thoroughly for monitoring visits to ensure efficiency and completeness, including sending pre-visit emails and re-evaluating visit times.
* Conduct visits per SOPs, WIs, and guidelines, applying MDR, ISO 14155, ICH / GCP, and Teleflex standards.
* Complete and maintain accurate Investigator Files and documentation before, during, and after visits.
* Present findings clearly to site staff, providing directions, retraining, and resolving data queries.
* Serve as a resource for site staff between visits for clarification and insights.
* Document visit reports and follow-up actions professionally, ensuring clarity and accuracy.
* Manage safety reporting, including collecting relevant documentation, reporting to Safety Officers, and ensuring compliance with local requirements.
* Assist in study-related projects, audits, and training activities.
* Conduct co-monitoring to ensure consistency with protocols and standards.
* Oversee training of new personnel and provide leadership within the team.
* Support regulatory inspections and audits.
* Train site staff on protocol, GCP, and data management as needed.
* Perform remote monitoring activities within timelines and follow up on queries.
* Coordinate with Medical Affairs, Sales, and administrative staff to support responsibilities.
* Ensure compliance with travel policies, complete expense reports, and manage data entry and queries.
* Participate in study team activities, prepare study documents, and contribute to ongoing communication with sites.
EDUCATION / EXPERIENCE REQUIREMENTS :
* Bachelor’s degree or higher in life sciences, nursing, or related fields, or equivalent qualification.
* Knowledge of the medical device sector.
* At least 5 years of on-site monitoring experience as a CRA in medical device/pharmaceutical industry or CRO.
* Strong attention to detail, organizational skills, and excellent interpersonal skills.
* Excellent clinical trial monitoring skills.
* Knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.
SPECIALIZED SKILLS & OTHER REQUIREMENTS :
* Strong understanding and application of MDR, ISO 14155, and ICH / GCP guidelines with a focus on compliance.
* Aptitude to learn and apply knowledge in relevant therapeutic areas.
* Ability to train and mentor staff for monitoring activities.
* Effective communication skills, both written and spoken in Italian and English.
* Ability to work independently, remotely, and travel internationally up to 70%.
* Proficiency with MS Office applications and experience with databases.
* Dedicated home office setup if working remotely.
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