Senior Clinical Research Associate (Senior CRA) responsible for scheduling and conducting on-site and remote monitoring visits in compliance with regulatory standards (MDR, ISO 14155, ICH/GCP), Teleflex procedures, and IRB/EC policies. The Senior CRA conducts monitoring visits to evaluate data accuracy and subject safety based on regulatory documents, medical records, reported data, and device storage where applicable. The role requires identifying issues, presenting findings to site staff, providing retraining as needed, offering problem-solving strategies, and communicating findings to the study team and management via monitoring visit reports and issue escalation. Minimum of 5 years of work experience as a clinical trial monitor. Assists the Management Team with training needs and provides input on monitoring tools and procedures.
Culture
Customer Experience – Representing Teleflex in a customer-facing position. All colleagues are expected to perform with professionalism, service, and ethics to strengthen Teleflex brand and customer relationships.
Principal Responsibilities
* Conducts monitoring within timelines according to the monitoring plan and Teleflex procedures.
* Schedule and conduct monitoring visits (site qualification, site initiation, routine monitoring, site closure) with Investigators and Research Coordinators.
* Evaluate quality and integrity of site practices and escalate quality issues as appropriate.
* Prepare for monitoring visits with the Teleflex Clinical Studies project team; escalate significant findings and provide input on site performance.
* Prepare for monitoring visits in advance (1–2 weeks prior for on-site and remote visits); optimize time on-site through thorough planning.
* Conduct monitoring visits per department SOPs, WIs, and monitoring plans; apply MDR, ISO 14155, ICH/GCP guidelines and Teleflex SOPs/WIs.
* Complete Investigator Files with all required documentation before site initiation, during enrollment and follow-up, and at site close-out.
* Present findings to site staff, provide clear resolution directions, retraining as needed, and review data queries for understanding and resolution.
* Serve as a resource to site staff between visits for data queries and visit preparation.
* Submit Monitoring Visit Reports (MVRs) and Follow-up Letters per Teleflex procedures; document action items with issues and resolutions.
* Collect necessary documents and contribute to filing; ensure compliance with safety reporting requirements (national/local).
* Collect local safety reporting information and report to Safety Officer at predefined timepoints; prepare safety-related submission documents to EC/NCA upon SO request; be the contact for national ECs and NCAs as requested by SO; follow up with sites on safety/adverse event tasks per SO requests; ensure local requirements are met for safety-related documents and reporting processes.
* Gather local data protection information and report to CPM prior to study start.
* Assist Clinical Project Manager in department and study-related projects (in-house audits, investigator meetings, training, etc.).
* Co-monitor with Clinical Studies personnel to ensure monitoring aligns with protocol, SOPs, WIs, and regulatory standards.
* Oversee training of newly hired Clinical Studies personnel; provide leadership to the RCRA Group for day-to-day responsibilities.
* Support adapting WIs and Guidelines to regulatory requirements; assist during safety inspections and audits by regulatory authorities.
* Conduct training visits to mentor staff on monitoring per protocol, GCP, data entry, and other regulations; train site staff on protocol requirements and develop general training materials as needed.
* Perform remote monitoring per plans and department needs within established timelines; resolve data queries.
* Interface with Medical Affairs, Sales, and Administrative staff as necessary; comply with Teleflex Travel Policy and submit accurate expense reports.
* Provide input to Medical Affairs, Sales, and Administrative Departments; manage eCRF completion and data query resolution within study guidelines.
* Participate in study teams and assist in developing conference calls, site FAQs, and other study documents.
Education / Experience Requirements
* Bachelor’s or higher degree in life sciences, nursing or related health discipline, or equivalent qualification.
* Knowledge of the medical device sector.
* Minimum of 5 years’ on-site monitoring experience as a CRA in medical devices, pharmaceuticals, or with a CRO.
* Strong attention to detail, organizational skills, and excellent people skills; excellent clinical trial monitoring skills.
* Previous knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.
Specialized Skills & Other Requirements
* Strong working knowledge of MDR, ISO 14155, and ICH/GCP guidelines; strong compliance focus.
* Aptitude to learn and apply knowledge in relevant therapeutic areas; ability to train and mentor staff for remote and on-site monitoring.
* Ability to train site staff on protocol, GCP, data entry, and regulations; maintain composure in challenging situations and adapt to shifting priorities.
* High attention to detail; ability to work independently in a regional area with remote supervision.
* Proficient medical terminology; effective time management and organizational skills; excellent written and verbal communication; strong interpersonal skills.
* Experience with spreadsheets and databases (MS Word, Excel); ability to work independently within Teleflex systems; capable of remote work and travel as needed.
* Fluent in Spanish and English (written and spoken); willing to travel internationally if necessary.
Travel Required
Up to 70%.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Project Management
* Industries: Medical Equipment Manufacturing
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