Interested in becoming part of our Clinical Operations Contractors database?

Version - v.0.1

Version Date - 5. 16. 2022

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OPERATIONS EXPERIENCE

Do you have Clinical Research Associate (CRA) experience?

CRA experience includes but is not limited to:


  • Monitoring activities at clinical study sites to assure adherence to GCPs, SOPs, study protocols and regulatory requirements.
  • Participation in study development, start-up activities, and clinical training programs.
  • Preparation of clinical documentation, business correspondence and procedural manuals.
Do you have Clinical Project Manager (CPM) experience?

Clinical Project Manager (CPM) experience includes but is not limited to:


  • Leadership/Management/Monitoring of project teams
  • Management of study timelines and quality standards
  • Coordination of activities across departments/vendors involved in a study
  • Development/Review of study management plans
  • Maintenance of study tools, training material, and SOPs
Do you have Regulatory Affairs Officer experience?

Regulatory Affairs Officer experience includes but is not limited to:


  • Planning and execution of regulatory matters pertaining to clinical trials
  • Collection and collation of regulatory application documentation
  • Review and preparation of regulatory documentation
  • Administrative support for Safety Team during trial
Do you have Medical Monitoring experience?
Do you have Auditor experience?

Auditor experience includes but is not limited to:


  • Collection, organization and analysis of compliance risk data
  • Development of a risk-based audit scope
  • Evaluation of internal controls, operating efficiency, and adequacy of recordkeeping.
  • Review of financial, operational, or regulatory compliance deficiencies
  • Investigation of irregularities discovered internally and externally
  • Compliance training oversight

DISEASE EXPERIENCE

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CV/RESUME


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INFORMATION PRIVACY POLICY

Information on FHI Clinical’s data protection requirements can be found here: https://www.fhiclinical.com/privacy-shield/