Seattle Clinical Research Center, formerly Seattle Women’s, is seeking a full-time Quality Control & Regulatory Coordinator to join our research team.
Seattle Clinical Research Center (SCRC) is a dedicated clinical trial investigative site. SCRC has successfully executed hundreds of multi-specialty Phase I-IV medical device and biopharma clinical trials since 1991 and has particular expertise in women’s health-related drugs and medical devices as well as migraine and vaccine studies.
Seattle Clinical Research Center is looking for a Quality Control & Regulatory Coordinator to join our team! The QC/Regulatory Coordinator will serve as an integral member of our team who helps to ensure high quality practices for site data collection and documentation. To be successful in this role, you should have acute attention to detail and be highly organized. Previous experience in clinical trials at a site or CRO/Sponsor level is required.
- Create and implement site processes that ensure high quality and consistent site practices
- Complete study start-up documents, i.e., FDA Form 1572, IRB Initial Submission, Financial Disclosure Forms, etc.
- Assist with maintenance of regulatory binders/ISF’s for 20-30 ongoing clinical trials
- Complete interim IRB reporting such as Continuing Review Reports, Unanticipated Event Reports, etc.
- Create study source documents
- Conduct QC/QA review of subject charts per ALCOA standards and site SOPs
- Perform internal audits in preparation of FDA and sponsor audits
- Maintain site SOPs
- Maintain all site staff training documentation
- Maintain site equipment calibration records, including scheduling annual equipment calibration with third party vendors
- Train staff on site regulatory best practices
This role is evolving, and opportunities to expand responsibilities and take on more challenging tasks will be readily available.
- Bachelor’s degree preferably in science, healthcare, or other related field or significant experience in research coordination or regulatory work may be substituted for educational requirements
- Previous experience with Phase I, II, III, or IV clinical trials, either at a site or Sponsor/CRO level
- Excellent written communication skills
- Acute attention to detail and exceptional organizational skills
- Be self-motivated and a fast learner
In accordance with Washington state law, Seattle Clinical Research Center requires that all employees be fully vaccinated against COVID-19. All offers are contingent and your vaccine status will be verified at onboarding.