Anthem, Inc. Clin Research Site Mgr-HC in Reston, Virginia
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 site related contact and administration, with guidance, for the HealthCore data research team.
Primary duties may include, but are not limited to:
Conducts study feasibility to identify ideal physician sites for study participation. May assist with development of the project plan based on prior study experience.
Guides sites through the confidentiality agreements, site contracts and regulatory document completion process in preparation for site for study participation. Collects, reviews, and maintains site essential documents (e.g., ICF, investigator contract, budget, payment schedule, etc.) for compliance with regulatory requirements, Standard Operating Procedures, and ensures HealthCore and Sponsor legal and business requirements are met.
Develops site materials, training documents and job aids.
Works in collaboration with data management staff to ensure timely and accurate entry of data collection into the Electronic Data Capture (EDC) system per protocol requirements and assists sites with query resolution.
Conducts site management calls and completes site monitoring reports as specified in the study contract and protocol.
Tracks accurate site progress and maintains site status updates using the approved Clinical Trial Management System (CTMS). Reviews CTMS for completeness of site progress and contact results and works with Clinical Study Associates to resolve issues to contribute to the success of the site and study.
Maintains and performs QC of the Trial Master File.
Provides protocol and study-related training to participating physician sites.
Provides updates to site management group on root cause for slow enrollment, poor quality or other issues; takes part in CAPA.
Contacts sites to assist with feasibility process.
Supports each site by providing Letters of Intent (LOI).
Supports the site through start up, with Confidentiality Agreement (CDA) collection through contract execution, as well as Institutional Review Board (IRB) approval.
Assists the site in identifying staff members necessary for preparation, enrollment follow up, and study related needs.
Ensures site related activities are recorded appropriately.
Guides site to final data entry and resolution in preparation for closeout.
Requires a BA/BS in a life sciences, health services, or related field required; 1-3 years of experience including clinical research; or any combination of education and experience which would provide an equivalent background. Ability to work on multiple projects is important. CRC experience is a plus.
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.