Clinical QA Associate in Duarte, CA at APEX Systems

Date Posted: 9/14/2019

Job Snapshot

Job Description

Job #:  980510
Large research institution in Duarte is seeking Clinical QA Associates to join their team!
 
Duties:
  • Verifies that required reporting of Serious Adverse Events (SAE) to all applicable regulatory agencies (FDA, OBA, RAC, NIH, NCI) has been completed in a timely manner.
  • Reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures.
  • Verifies that required reporting of protocol deviations, unanticipated problems, and Serious Adverse Events (SAE) to internal organizations (IRB, CPRMC, IBC, OSBC, RSC, DSMC) has been completed in a timely manner.
  • Audits or monitors study data, including the consent process, eligibility criteria and case report forms, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. Verifies that corrections to the CRFs are made correctly, if applicable.
  • Generates audit reports and monitoring reports, summarizing the findings of all protocol deviations,, discrepancies, and incorrect or missing data. When direction is needed, provides training for sponsors, principal investigators, CRCs, and clinical research nurses.
  • May be required to travel to other participating sitesup to approximately 15% of the time to perform audits or monitoring of enrolled subjects as described above

Requirements:
  • BS in scientific field
  • 2+ years working as a CRA or CTA

Preferred:
  • Experience in hematology or oncology
  • Experience with clinical trials or as an regulatory affairs admin
  • Knowledge on New Drug Procedures 

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.