Location: Los Angeles, CA
Description: Our client is currently seeking a Clinical Research Associate Sr-HC
This job will have the following responsibilities:
- Functions as primary contact and provides on-site guidance for site research staff.
- Leads the development of Site Monitoring Plan.
- Reviews and leads the study progress and enrollment at the site.
- Conducts remote and/or on-site Site Qualification Visits (SQV) and Site Initiation Visits (SIV), as well as on-site routine/Interim Monitoring Visits (IMV) to clinic sites and local/central laboratories to assess protocol compliance, review regulatory documents, monitor pharmacy records, and conduct source document verification.
- Assist Medical Monitor in obtaining source documents related to adverse events, assist with the preparation of safety reports for the FDA and other regulatory bodies for IND trials.
- Assists with the development and training of other department members. Requires a BS in a life sciences, health services, or related field required; 5 years of clinical experience including site monitoring; or any combination of education and experience which would provide an equivalent background. Working knowledge of ICH-GCP guidelines and FDA regulation as a result of clinical research experience. SOCRA or ACRP certificate preferred. Willingness to travel.
Qualifications & Requirements:
- Requires a BS in a life sciences, health services, or related field required
- 5 years of clinical experience including site monitoring; or any combination of education and experience which would provide an equivalent background.
- Working knowledge of ICH-GCP guidelines and FDA regulation as a result of clinical research experience. SOCRA or ACRP certificate preferred.
- Willingness to travel.
Contact: khawkins@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com