Freelance Clinical Research Associate (CRA) - Italy

JOB SUMMARY

This is a Freelance position (0,2 - 0,8FTE) for a clinical trial project based in Italy. Under the direction of the Director of Clinical Operations, the Sr. CRA will implement and coordinate assigned projects, pre-market trials, and post-market registries. The CRA will perform the job according to intern SOP and external requirements. 

KEY RESPONSIBILITIES

• Develop clinical research strategies and clinical trial protocols with the support of external advisors/consultants, as applicable. 
• Managing all aspects of submissions to the locals' Ethics Committees; clinical trial contract negotiations; Patient Informed Consent (PIC) development, case report form (CRF) design and implementation.
• Strong knowledge of local clinical sites and Ethics Committees.
• Database management (data collection, review, and query).
• Maintaining close contact with the local study site coordinators and investigators.
• Leading the clinical team to successfully drive clinical studies under appropriate quality standards, including ICH/GCP, ISO, MDD, MDR, and applicable global regulations, along with company compliance requirements. 
• Lead clinical scientific discussions with local regulatory agencies, investigators, and clinical key opinion leaders (KOL).  
• Drives setting of team goals and milestones; monitors progress.
• Develop and maintain relationships with investigators, coordinators, and site staff.
• Provide project/study management and monitoring plans for projects.
• Safety analyses and safety assessments (or appoint designee).
• Write and review publications which originate from the clinical activities (or appoint designee).

QUALIFICATIONS/REQUIREMENTS 

• This person needs to be based in Italy, knowledgeable in Italian sites. (Mandatory)
• This person must have more than 5 years of past experience as a CRA. (Mandatory)
• Demonstrable experience in clinical trials and monitoring. (Mandatory)
• Medical device experience. Proficient knowledge of cardiovascular medical terminology. Advanced knowledge of clinical and outcomes research study design. (Mandatory)
• Experience as a Clinical Research Consultant. (Mandatory)
• Experience with Medical Devices. (Class-III Devices is preferred)
• Computer proficiency (Microsoft® Office). 
• Good communication and organizational / time management skills.
• Self-motivation with the ability to work under pressure to meet deadlines.
• Detail and process-oriented, positive attitude and approach, multi-tasking capability.
• Working knowledge of FDA regulation/ ICH guidelines / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures.
• Bachelor's degree in life sciences.
• Advanced degree (Masters or PhD) preferred.
• Italian Speaker. (Mandatory)

Send an email with your CV and coverletter to matias.fernandez@akrnconsulting.com