Clinical Research Associate

Position Summary

The Clinical Research Associate (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 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 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 CRA has a minimum of 2 years of work experience as a clinical trial monitor.  The CRA assists the Management Team with training needs. 

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 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.
•    Conducts monitoring visits per the department SOP, WIs and monitoring plans.  Applies MDR, ISO 14155, ICH/GCP guidelines and Teleflex SOP and WIs to monitoring activities.
•    Completes the Investigator Files with all appropriate documentation. Ensures all required documentation is completed prior to site initiation, during enrollment and follow-up, and at site close out.
•    Presents findings to site staff.  Provides clear directions for resolution.  Provides appropriate retraining. 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. 
•    Completes professional, accurate and succinct Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures. 
•    Professionally documents monitoring visit action items.  Action items will clearly identify the issue and suggest accurate instructions for resolution. 
•    Collect necessary documents and contribute to document filing. 
•    Ensures compliance with national and local safety reporting requirements.
•    Collect information of local safety reporting requirements and report to Saftey Officer (SO) at pre-defined timepoints 
•    Prepare national safety related submission documents to EC / NCA upon request by SO
•    Be contact for national EC(s) and NCA regarding safety reporting upon request by SO
•    Submission of local safety documentation to EC / NCA upon request by SO
•    Follow up with study sites of Safety/Adverse event related tasks upon request by SO
•    Ensuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processes
•    Collect local data protection requirement information and report to CPM prior to study start
•    Assists the Clinical Project Manager department and 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 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. 

Education / Experience Requirements

•    Bachelor's or Graduate degree in life sciences, nursing or other health related disciplines or a comparable qualification. 
•    Minimum two years of 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 set up including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment.
•    Fluent (written and spoken) in German. 
•    Fluent (written and spoken) in English.
•    If necessary, international travel. 

We offer a permanent position classified in Group E in accordance with the Austrian Collective Agreement for Employees and Apprentices in Commercial Enterprises.
The minimum monthly gross salary under the collective agreement is € 3.437 ,– gross (full-time, 38.5 hours per week).
We are committed to offering a competitive salary and therefore guarantee a minimum annual gross salary of € 65.000, with the possibility of overpayment depending on your qualifications and experience

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