Anthem, Inc. Clinical Research Associate Sr-HC in Indianapolis, Indiana
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.
Responsible for providing all on-site related contact and administration, for the HealthCore Clinical Research team.
Open to ANY Anthem location
Primary duties may include, but are not limited to :
Functions as primary remote and/or on-site contact and provides on-site guidance for site research staff.
Performs on-site monitoring and oversight activities using various tools to ensure: data generated at the site are complete, accurate, and unbiased, subjects rights, safety and well-being are protected
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, SOPs, Protocol, Site Monitoring Plan and associated documents
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.
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Requires a BS in a life sciences, health services, or related field required; 5+ years of clinical experience including a minimum of 4 years of direct site management (monitoring) experiences in Bio/Pharma/CRO required; 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. Rheumatology experience preferred .
Willingness to travel.
Anthem, Inc. has been named as a Fortune 100 Best Companies to Work For® , is ranked as one of the 2020 World’s Most Admired Companies among health insurers by Fortune magazine, and a 2020 America’s 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.