Anthem, Inc. Clinical Research Associate/Senior-HC in Thousand Oaks, California
SHIFT: Day Job
Your 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.
Please note this position can be hired at either the Associate or Associate Sr level at Hiring Manager's discretion
Preferred Locations - Delaware, Virginia, Connecticut, Massachusetts, Georgia, Pennsylvania, Indiana, New York, California, Illinois, Florida
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.
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 25-50%.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Anthem, Inc. is ranked as one of America’s Most Admired Companies among health insurers by Fortune magazine and has been named a 2019 Best Employers for Diversity by Forbes. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran. Anthem promotes the delivery of services in a culturally competent manner and considers cultural competency when evaluating applicants for all Anthem positions.