Skip to content

Job Openings

Clinical QA Consultant

REMOTE, CA 94080

Posted: 01/17/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 536585 Is job remote?: Yes Country: United States

Job Description

Job Description:
  • Ensure the quality and compliance of clinical activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
  • Prepare and conduct or assist/oversee contract auditors for GxP audits per established strategies
  • Audit, as required, and provide audit results to stakeholders and support process improvement activities asa subject matter expert (SME) in GCP/GPvP/GLP
  • Support the development of internal systems for the maintenance of internal audit files, Tracking Log and related Clinical QA outputs/summaries/metrics.
  • Establish contract agreements and Statement of Works (SOWs) with Clinical QA consultants, according to the internal process. with Legal input
  • Conduct/oversee Clinical QA review of draft protocols; Informed Consent Forms, aggregate safety reports, clinical study reports and other clinical trial specific documents, when requested
  • Conduct/oversee risk-based audits of service providers, internal systems and clinical investigators involved with clinical trial programs
  • Conduct/oversee of regulatory training for GCP/GPvP/GLP as needed
  • Conduct the review of clinical trial related SOPs
  • Support efforts to enhance and establish a corporate-wide Quality Management System (QMS)
  • Lead in the inspection readiness activities; attend clinical trial team meetings, provide Clinical QA advice, as necessary to clinical teams and functions
  • Maintain working knowledge of FDA, EU and other global regulations and guidance governing GCP/GPvP/GLP.
  • Maintain file organization within the Clinical Quality Assurance Department
  • Other duties as assigned

  • Excellent understanding of Clinical Development Process
  • Experience writing and reviewing SOPs which support clinical trials•Good understanding of FDA GCP and ICH regulatory requirements and implementation
  • Good knowledge of Computer System Validation (CSV) in association with GCP/GPvP/GLP audits
  • Good knowledge of clinical laboratory requirements and method validation
  • Effective communication (verbal and written)
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
  • An ability to be productive and successful in an intense work environment
  • Experience with participating in global regulatory inspections

  • Minimum Bachelor’s degree in a healthcare or scientific-related discipline with 8 years for experience in GCP/GPvP/GLP quality assurance experience in a pharmaceuticals or biotechnology industry (an equivalent combination of experience and education may be considered)
Target Pay Rate Range: $90-$100/hr. Salary will be commensurate with experience 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial