Clinical Quality Assurance Assistant

Company History:

Integrium is a full-service (CRO) Firm focused on drug and device development within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Diseases.

Job summary:

Integrium is looking to hire a Clinical Quality Assurance Assistant in our Tustin, CA office. The Clinical Quality Assurance Assistant is responsible for conducting internal audits; including, but not limited to audits of internal databases, Trial Master Files, shipment audits, system and process audits. The Clinical Quality Assurance Assistant may also conduct protocol and informed consent reviews and assist the Quality Systems Manager in review of internal Sponsor/Client audits. He/she responsible for ensuring that audits are performed per Integrium processes and meet all aspects of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) regulations.

Education And Experience Required:

  • Bachelor’s Degree preferred; And/or 2+ years of industry related experience.
  • MUST HAVE PREVIOUS EXPERIENCE WORKING FOR A CRO AND/OR PHARMACEUTICAL, COMPANY.
  • Previous Site Coordinator or Clinical Study Coordinator experience strongly preferred.
  • Experience in conducting internal compliance audits.
  • Strong understanding of Clinical Development Process.
  • Strong understanding of FDA GCP and ICH regulatory requirements and implementation.
  • Experience in interpreting the requirements of a study protocol and conveying the details accurately to study personnel.
  • Computer proficiency in Microsoft Office with a focus on Word, Excel and Outlook required.
  • Strong attention to detail and accuracy a must.
  • Strong commitment to quality and problem-solving skills required.
  • Must be customer oriented and flexible.
  • Ability to work independently and in a team environment, as well as the ability to work well with others in high pressure situations.
  • Excellent ability to communicate effectively and clearly, both orally and in writing.
  • Exceptional organizational and time management skills and ability to multi-task projects for timely completion.
  • Travel of less than 5%.

Essential Job Functions:

  • Conduct assigned audits assigned by the Quality Systems Manager once determined qualified per the Quality Assurance Assignment Form.
  • Audits assigned may include, but are not limited to internal databases, Trial Master Files, shipment audits, system and process audits.
  • Conduct protocol and informed consent reviews and assist the Quality Systems Manager in review of internal Sponsor/Client audits.
  • Maintains knowledge and conduct audits in compliance with Quality Systems Corporate Policies (CP), Standard Operating Procedures (SOP) and Working Instructions (WI).
  • Strict adherence to company and/or Sponsor SOPs WIs and CPs.
  • Represent Integrium’s service commitment of integrity, integration, initiative and intelligence on a consistent basis with all interactions encountered.

*MUST BE WILLING TO WORK FROM OUT TUSTIN, CA OFFICE DAILY!!!!!

Additional Skills And Competencies:

  • Ability to work on multiple tasks and projects.
  • Ability to provide technical expertise.
  • Ability to work in a multi-disciplinary team setting.
  • Computer proficient in a Microsoft Windows environment.
  • Good organizational skills.
  • Strong leadership skills.
  • Strong interpersonal skills.
  • Excellent problem-solving skills.
  • Strong attention to detail and accuracy.
  • Strong commitment to quality.
  • Must be customer oriented and flexible.
  • Must be able to work independently and in a team environment and working well with others in high pressure situations.
  • Excellent ability to communicate effectively and clearly, both orally and in writing.
  • Exceptional organizational and time management skills and ability to multi-task projects for timely completion.

Integrium also provides a benefits package that includes:

  • 4.5 weeks PTO annually
  • Opportunity to work from home once training is complete
  • Flexible work schedule
  • Health Insurance (PPO, HSA)
  • Dental and Vision plan
  • Prescription Drug plan
  • Life Insurance
  • Short-term Disability
  • Long-term Disability
  • FSA
  • 401(k) Plan with employer match

Equal Opportunity/Affirmative Action Employer

Integrium, LLC strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.