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.
All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers.
Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.
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 incl. site qualification, site initiation, routine monitoring and site closure visits.
Evaluate quality and integrity of site practices while escalating quality issues as appropriate.
Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and proactively provides input on site performance.
Adequately prepares for monitoring visits to ensure monitoring activities are organized, well planned, efficient and thorough. Prepares site email 1-2 weeks prior to on-site and remote monitoring visits. Re-evaluates time necessary for on-site visits. Maximizes time on-site through visit preparation.
Ensures all required documentation is completed prior to site initiation, during enrolment and follow-up, and at site close out.
Presents findings to site staff. Reviews data queries with site staff to ensure they are understood and can be resolved.
Serves as a resource to clinical site staff between visits to provide clarification and insights regarding data queries, action items and visit preparation.
Collect local data protection requirement information and report to CPM prior to study start
Assists the Clinical Project Manager in the department and in study related projects as requested including in-house audits, investigator meetings, training, etc.
Conducts co-monitoring with Clinical Studies personnel to confirm monitoring is conducted consistently with the protocol, department SOP, WIs and monitoring plans and regulatory standards.
Oversee training of newly hired Clinical Studies personnel. Provide leadership to the RCRA Group performing day-to-day responsibilities for clinical studies.
Preparation and support during safety inspections and audits by regulatory authorities.
Conducts training visits with Clinical Studies personnel to train and mentor individuals on conducting monitoring consistent with the protocol, department SOP, WIs and monitoring plans and regulatory standards.
Provide training of site to protocol requirements. Develop and oversee training for general research and site management. May conduct ongoing general training calls with site staff per study needs.
Performs remote per monitoring plans and department needs within the established timelines and follows queries to resolution.
Interfaces with Medical Affairs, Sales and administrative staff as necessary to accomplish the above responsibilities.
Complies with the Teleflex Travel Policy. Provides input to Medical Affairs, Sales and Administrative Departments as necessary to accomplish the above responsibilities.
Manage and assist eCRF completion, data query resolution within study guidelines.
Participate in the study team and assist on development of conference calls with site staff, FAQs, and other study documents.
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.
Strong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH/GCP guidelines governing clinical trials. 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.
Experience working independently in a regional area with remote or minimal supervision.
Proficient knowledge of medical terminology.
Excellent professional writing and oral communication skills.
Experience with spreadsheets, and databases applications (e.g., MS Word and Excel)
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 REQUIRED :