Senior Clinical Research Associate

Overview

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 required by 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 the site staff, provide retraining if needed, provide 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 assists the Management Team with training needs as well as developing and providing input on monitoring tools and procedures.

Principal Responsibilities

• Conducts monitoring within timelines and according to the monitoring plan and Teleflex procedures.
• Works cooperatively with Research Coordinators and Investigators to schedule and conduct monitoring visits including site qualification, site initiation, routine monitoring and site closure visits.
• Evaluate quality and integrity of site practices while escalating quality issues as appropriate.
• Prepare for monitoring visits with the Teleflex Clinical Studies project team, escalate significant findings during visits, and provide input on site performance.
• Prepare for monitoring visits to ensure activities are organized, well planned, efficient and thorough; prepare site emails 1-2 weeks prior to visits; re-evaluate time necessary for on-site visits; maximize time on-site through visit preparation.
• Conduct monitoring visits per department SOP, WIs and monitoring plans; apply MDR, ISO 14155, ICH / GCP guidelines and Teleflex SOP and WIs to monitoring activities.
• Complete the Investigator Files with all appropriate documentation; ensure required documentation is completed prior to site initiation, during enrolment and follow-up, and at site close out.
• Present findings to site staff; provide clear directions for resolution and appropriate retraining.
• Review data queries with site staff to ensure understanding and resolution; serve as a resource between visits for clarification and insights on data queries and visit preparation.
• Complete professional, accurate Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures; document monitoring visit action items with clear issues and resolution instructions.
• Collect necessary documents and contribute to document filing; ensure compliance with national and local safety reporting requirements; collect information on local safety reporting and report to Safety Officer (SO) at predefined timepoints; prepare safety submission documents to EC / NCA as requested by SO.
• Act as the contact for national EC(s) and NCA regarding safety reporting upon request by SO; follow up with study sites on Safety / Adverse event related tasks; ensure safety-related document requirements and reporting processes meet national/local requirements.
• Gather local data protection requirement information and report to CPM prior to study start.
• Assist the Clinical Project Manager in department and study projects (in-house audits, investigator meetings, training, etc.).
• Conduct co-monitoring with Clinical Studies personnel to confirm protocol, SOP, WIs and monitoring plans are followed; oversee training of newly hired personnel; provide leadership to the RCRA Group in day-to-day responsibilities.
• Support adaptation of WIs and Guidelines to applicable regulations; prepare for safety inspections and audits; conduct training visits to train and mentor staff on monitoring per protocol, GCP, data entry and regulatory standards.
• Develop and oversee training for general research and site management; conduct ongoing training calls with site staff as needed.
• Perform remote monitoring per monitoring plans and department needs within established timelines; interface with Medical Affairs, Sales and administrative staff as necessary.
• Comply with Teleflex Travel Policy; complete expense reports; provide input to Medical Affairs, Sales and Administrative Departments; manage eCRF completion and data query resolution.
• Participate in study team activities and assist with development of conference calls with site staff, FAQs, and other study documents.

Education / Experience Requirements

Bachelor’s or higher-level degree in life sciences, nursing or other health related disciplines or have a comparable qualification. Knowledge of the medical device sector. A minimum of 5 years’ on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO. High level of attention to detail and strong organizational ability paired with excellent people skills. Excellent clinical trial monitoring skills. Previous knowledge of Vascular Interventional Cardiology and / or Peripheral Vascular Intervention is an advantage.

Specialized Skills & Other Requirements

Strong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH / GCP guidelines governing clinical trials. Strong compliance focus. Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge. Ability to train and mentor Clinical Studies personnel for remote and on-site monitoring visits. Ability to train on site staff on the protocol, GCPs, data entry and other pertinent regulations. Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams. High attention to detail and accuracy. Experience working independently in a regional area with remote or minimal supervision. Proficient knowledge of medical terminology. Effective time management and organizational skills. Excellent professional writing and oral communication skills. Excellent interpersonal skills. Experience with spreadsheets and databases applications (e.g., MS Word and Excel). Ability to work independently within Teleflex systems. Ability to work independently and as a part of a team. Responsible for adequate and reasonable home office setting including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment. Fluent (written and spoken) in Italian. Fluent (written and spoken) in English. If necessary, international travel.

Travel

TRAVEL REQUIRED: Up to 70%.