11 Jun
Clin Research Assoc Sr-HC (PS35404)
Georgia, Midland 00000 Midland USA

Vacancy expired!

Description SHIFT: Day JobSCHEDULE: Full-timeYour Talent. Our Vision. At HealthCore, Inc., an independently-operating subsidiary of Anthem, Inc. and a health services research firm, it’s a powerful combination. It’s the foundation upon which we’re creating greater access to care for our members, greater value for our customers and greater health for our communities. Join us and together we will drive the future of health care.Your Talent. Our Vision. Responsible for providing all on-site related contact and administration, for the HealthCore early phase data research team.Primary duties may include, but are not limited to:

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.

Qualifications Requires a BS in a life sciences, health services, or related field required; 5 years of clinical experience including 2+ years of independent onsite monitoring experience; or any combination of education and experience which would provide an equivalent background. Experience with health plan administrative databases (pharmacy and medical claim, preferred). Proficiency in Microsoft Suite products. Attention to detail and accuracy in work. Excellent time management and organization skills. Ability to assess and troubleshoot problems onsite. Working knowledge of ICH-GCP guidelines and FDA regulation as a result of clinical research experience. SOCRA or ACRP certificate preferred. Willingness to travel (50%-75%).AnEqualOpportunityEmployer/Disability/Veteran.Anthem, Inc. is ranked as one of America’s Most Admired Companies among health insurers by Fortune magazine and is a 2018 DiversityInc magazine Top 50 Company for Diversity. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran.REQNUMBER: PS36404

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