Sr. Clinical Research Associate, IQVIA
$101,600–$169,300 year
On-siteCleveland, Ohio, United States
Job Summary
Conduct site monitoring visits, including selection, initiation, and close-out, ensuring adherence to protocol, Good Clinical Practice, and regulatory guidelines. Drive subject recruitment plans to enhance predictability while administering protocol training and managing ongoing project expectations. Evaluate site practices for quality and integrity, escalating issues as needed, and manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data query resolution. Maintain Trial Master Files and Investigator's Site Files, submitting regular visit reports and documentation. Collaborate with study teams and support start-up phases as applicable.
Required Qualifications
- at least 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
Desired Qualifications
- Bachelor's Degree in scientific discipline or health care preferred
- experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory
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