Sr. CRA 1, Oncology, IQVIA Biotech
$87,200–$169,300 year
On-siteSalt Lake City, Utah, United States
Job Summary
Conduct site monitoring visits, including selection, initiation, monitoring, and close-out, ensuring sites adhere to the study protocol, regulations, and Good Clinical Practice. Manage subject recruitment plans, track regulatory submissions, and oversee case report form completion and data query resolution. Administer protocol training to sites, evaluate the quality of site practices, and escalate quality issues as appropriate. Maintain Trial Master File and Investigator's Site File documentation, submit regular visit reports, and generate follow-up letters. Collaborate with the study team to support project execution and manage assigned studies from start-up through close-out.
Required Qualifications
- Minimum of 2 years of on-site monitoring experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements
- Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Good therapeutic and protocol knowledge
- Bachelor's Degree in scientific discipline or health care
Desired Qualifications
- Bachelor's Degree in scientific discipline or health care preferred
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