Yoh has a direct hire opportunity for a Field Monitor/ Clinical Research Associate to join our client in San Diego, CA.
The Clinical Research Associate manages all aspects of site monitoring responsibilities for clinical trials according to Good Clinical Practices (GCPs), SOPs, ICH guidelines and study protocols, including pre-study, initiation, interim and closeout visits.
- Prepares study manuals, informed consent documents, regulatory binders, enrollment tracking reports and other documents required for study conduct.
- Assists with study start-up activities.
- Conducts 8 to 10 site visits per month - pre-study, initiation, interim, and closeout visits.
- Creates site visit reports.
- Prepares accurate and timely trip and expense reports.
- Fields daily phone calls from sites and addresses issues in a timely manner.
- Develops plan to assess slow-enrolling sites, identifying and resolving root problems.
- Performs advanced in-house data review to ensure data integrity.
- Creates draft CRF Completion Guidelines, reviews data regularly through EDC system(s).
Discover all that's possible with Yoh. Apply now.
- R.N. or Bachelor's degree in nursing, pharmacy, the life sciences, or a related health field. OCN a plus.
- Three plus (3+) years of experience in a pharmaceutical or biotechnology company or CRO as a CRA with field monitoring and EDC experience.
- Oncology monitoring experience within the past 12 months required.
- Strong understanding of oncology and oncology trials including medical terminology and science.
- CRA certification a plus.
- Ability to work in a fast-paced environment with changing and competing priorities.
- Solid knowledge of Good Clinical Practice regulations, ICH guidelines, and internal SOPs necessary to monitor a site.
- Ability to work independently as well as in a team matrix organization with little or no supervision.
- Ability to prioritize work in order to meet demanding timelines.
- Excellent written and verbal communication skills.
- Strong detail orientation.
- Proficiency using MSOffice
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions .
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
Yoh Services, LLC - 2 years ago
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Yoh Company is a unit of Yoh, one of the largest staffing services firms in the United States with more than 550 million USD in total...