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.
The position of Clinical Research Site Manager, Senior is responsible for all site related contact and management. The Clinical Research Site Manager, Senior acts as a mentor for the Clinical Research Site Manager roles. The Clinical Research Site Manager, Senior may reach out to sites to facilitate completion of the feasibility and/or contracting process. They may offer expertise in taking the site through start up beginning with Confidentiality Agreements (CDA) collection through contract execution and Investigational Review Board (IRB) approval. The Clinical Research Site Manager, Senior will then focus on site management and handle higher-level issues related to training, enrollment follow-up, and payments. The Clinical Research Site Manager, Senior is expected to be a “protocol expert” and expert site trainer, and will contact the site as needed to contribute to the success of the site and study. This role may also be responsible for training other Site Managers on the protocol or other study related material. The Clinical Research Site Managers, Senior is expected to track all site related activities in the project Clinical Trial Management System (CTMS) and review/complete site contact reports per the Site Management Plan (SMP). The Clinical Research Site Manager, Senior may serve as a site manager on small to mid-range studies as needed. The CRA 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. Serves as an in-house resource to the data manager, research assistant and programming staff.
Primary duties may include, but are not limited to:
- Update appropriate systems on site progress
- Attend study team meetings as applicable
- Manages difficult sites or troubleshoots issues with under-performing sites
- Mentor Clinical Research Site Associates
- Coordinates and identifies sites and assists with feasibility and/or contracting process.
- Offers expertise to sites, to ensure start up, with Confidentiality Agreement (CDA) collection through contract execution, as well as Institutional Review Board (IRB) approval.
- Assists with elevated questions in identify staff members for necessary preparation, enrollment follow up and study related needs.
- Supports the development of the site project plan.
- Assists with the development and training of other department members.
- Assist with and/or lead the development of site materials.
- Undergraduate degree (BA/BS) in life sciences, health services, or related field required; 3+ years clinical research experience; or any combination of education and experience which would provide an equivalent background. Master’s degree (MS/MPH) with 2 years of clinical research experience, preferred.
- CRA certification (SOCRA, ACRP), preferred.
- Must have working knowledge of GCP, ICH and FDA regulations, 3+ years with site support, preferred.
- Ability to work on multiple projects is important
- Proficiency in database and word processing software, e.g. Microsoft Word, Microsoft Excel
- Effective communication and interpersonal skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Attention to detail and accuracy in work
- Excellent time management and organizational skills
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.