Freelance Clinical Research Associate (CRA) - Greece

AKRN Scientific Consulting

Greece


Job description

 

JOB SUMMARY

 

This is a Freelance position (0,2 - 0,8FTE) for a clinical trial project based in Greece. 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 Greece, knowledgeable in Greek 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.
  • Greek Speaker. (Mandatory)

 

Send an email with your CV and coverletter to [email protected]



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