Junior Data and Safety Auditor

4 weeks ago

San Francisco, California, United States Penn Foster Inc Full time
Job Summary

We are seeking a highly motivated and detail-oriented Junior Data and Safety Auditor to join our team. The successful candidate will be responsible for conducting audits of clinical trials to ensure compliance with regulatory requirements and good clinical practice guidelines.

Key Responsibilities
  • Conduct audits of clinical trials to identify non-compliance and significant findings
  • Communicate findings to supervisors and stakeholders in a timely manner
  • Assist with audit and inspection preparation for industry-sponsored quality assurance audits and FDA inspections
  • Attend DSMC meetings and assist with agenda, minutes, and facilitation
  • Stay up-to-date with relevant regulations, policies, and guidelines
Requirements
  • Bachelor's degree in a related field and/or equivalent experience
  • Minimum 1 year experience in clinical research or equivalent experience in a pharmaceutical company
  • Proven ability to synthesize medical information and determine if medical information has been abstracted and recorded correctly
  • Independence, planning, and decision-making abilities to complete assigned duties
  • Knowledge of relevant Federal and State regulations, and policies
Preferred Qualifications
  • Relevant compliance certification (if applicable)
  • SoCRA or ACRP Certification
  • Proven ability to understand oncology, specific organ cancers, and standard of care treatments
  • Knowledge and experience with quantitative and qualitative research design
About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity, and excellence – also known as our PRIDE values.

The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

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