Freelance Clinical Research Associate (CRA) - UK

AKRN Scientific Consulting

United Kingdom


Job description

JOB SUMMARY

This is a Freelance position (0,8FTE) for a clinical trial project based in the UK towards London, Bristol and Sussex area. 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 in, related to Class II and Class III implantable products. 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 UK based, knowledgeable in UK sites towards the London area. (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.
  • English Native Speaker. (Mandatory)

Send an email with your CV and cover letter to:  [email protected]



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