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Clinical quality assurance associate skills for your resume and career

Updated January 8, 2025
1 min read
Below we've compiled a list of the most critical clinical quality assurance associate skills. We ranked the top skills for clinical quality assurance associates based on the percentage of resumes they appeared on. For example, 30.0% of clinical quality assurance associate resumes contained clinical practice as a skill. Continue reading to find out what skills a clinical quality assurance associate needs to be successful in the workplace.

11 clinical quality assurance associate skills for your resume and career

1. Clinical Practice

Here's how clinical quality assurance associates use clinical practice:
  • Adhere to all study specific protocols, SOP's, good clinical practices and regulatory compliance
  • Audit several clinical studies and therefore have good knowledge of GCPs (Good Clinical Practices).

2. Investigator Sites

Here's how clinical quality assurance associates use investigator sites:
  • Performed audits of Databases, Trial Master Files, Investigator Sites, and Vendors.
  • Developed and presented GCP training programs at Investigator's Meetings and investigator sites.

3. Clinical Quality Assurance

Here's how clinical quality assurance associates use clinical quality assurance:
  • Hired, trained and supervised a Clinical Quality Assurance Assistant.

4. GCP

Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.

Here's how clinical quality assurance associates use gcp:
  • Provided strategic direction and operational focus for the GCP QA unit during the company-wide re-organization.
  • Developed GCP standards and procedures consistent with current global regulatory requirements.

5. Internal Audit

Internal audit is an evaluation process that ensures that a company's risk management, governing body, and other internal processes are running effectively. People who perform internal audits must be highly qualified, have experience, and knowledge to work accordingly with the international standards and the code of ethics.

Here's how clinical quality assurance associates use internal audit:
  • Trained in appropriate Data Management processes for future internal audit purpose.
  • Prepare and conduct internal audits of key company processes (training, etc.)

6. External Audits

Here's how clinical quality assurance associates use external audits:
  • Addressed non-conformance reports resulting from external audits and worked with department managers to understand process breakdowns and areas for improvement.
  • Provide technical assistance as assigned to unfavorable external customer monitoring, external audits or internal reviews regarding project compliance.

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7. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how clinical quality assurance associates use fda:
  • Performed internal reviews of clinical records in the US and Belgium, resulting in two successful FDA audits.
  • Interpreted FDA guidance and comparable internal regulations, standard operating procedures, and other company policies and procedures on regulatory compliance.

8. Regulatory Compliance

Here's how clinical quality assurance associates use regulatory compliance:
  • Maintained documents tracking database and monthly product status reports; ensured clinical trial documentation integrity and regulatory compliance.
  • Worked in partnership with Manufacturing, Quality Control and Regulatory Compliance Departments to maintain compliance with regulatory bodies and customer expectations.

9. Conduct QA

Here's how clinical quality assurance associates use conduct qa:
  • Conduct QA review and approve all manufacturing/processing batch records and quality test records.

10. CAPA

Here's how clinical quality assurance associates use capa:
  • Participated in CAPA process; provided product and system performance metrics, consulted in domestic and international regulatory matters.
  • Managed CAPA training and certification program, implementing consistent process application and skill development to ensure global regulatory compliance.

11. Approvals

Here's how clinical quality assurance associates use approvals:
  • Performed Final Batch Record Review and Approval for cGMP and GDP compliance.
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List of clinical quality assurance associate skills to add to your resume

Clinical quality assurance associate skills

The most important skills for a clinical quality assurance associate resume and required skills for a clinical quality assurance associate to have include:

  • Clinical Practice
  • Investigator Sites
  • Clinical Quality Assurance
  • GCP
  • Internal Audit
  • External Audits
  • FDA
  • Regulatory Compliance
  • Conduct QA
  • CAPA
  • Approvals

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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