HealthCore, Inc., a health services research firm headquartered in Wilmington, DE is seeking an experienced Lead Clinical Study Associate to join the team in our Wilmington, DE; Andover and Watertown, MA; or Alexandria, VA locations. Founded in 1996, and now an independently-operating subsidiary of Anthem, Inc., HealthCore provides the health care system, biopharmaceutical industry, academia, as well as federal and state governments with "real-world" data to improve the quality, safety, and affordability of healthcare. HealthCore’s projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.
The primary role of the Lead Clinical Study Associate is to provide oversight of all contact and management of sites participating in HealthCore’s late phase research studies. This includes, but is not limited to Pragmatic Clinical Trials (PCTs), Post-Authorization Safety Studies (PASS), and Disease or Product Registries.
Represents the site-based functions in client-facing and internal meetings.
Provides site-based input to proposals and protocols.
Contributes to budget content and leads initial budget build.
Helps build project specific tools, such as the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), and project plans to provide guidance and oversight to sites.
Provides site-based input to other study-related plans including Data Management Plans (DMP) and Statistical Analysis Plans (SAP).
Acts as escalation point for issues arising from study feasibility and site identification through site closeout.
Assigns Clinical Study Associates (CSA)s to sites based on experience, geographic location, and time coverage.
Ensures project team is trained on project materials, HealthCore SOPs, and study materials.
Reviews and ensures adherence and signoff on remote monitoring and site management call reports.
Reviews CTMS for completeness of site progress and contact results and works with CSAs to resolve tracking issues.
Monitors overall study progress daily/weekly and proactively develops or adjusts plans, as needed, to achieve targets.
Provides guidance on site enrollment or troubleshooting strategies.
Assists the functional lead to resolve study or client-related issues.
BS degree in a life sciences field or relevant education and/or equivalent training in health services research, or a related field; 7+ years in a clinical research function with direct late phase research experience.
Requires excellent oral and written communication skills.
Effective time management and the ability to work on multiple and varied tasks.
Working at HealthCore:
In addition to a dynamic work environment, HealthCore offers a competitive salary and comprehensive benefits program, including a 401(k) plan; health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance coverage; tuition assistance, paid parking, and an employee stock purchase plan.
HealthCore is headquartered in Wilmington, DE, midway between New York City and Washington, DC, with offices in Andover and Watertown, MA and Alexandria, VA. As an independently operating subsidiary of Anthem, Inc., HealthCore offers the resources of the nation’s leading health benefits company in a small company environment. To learn more about us or apply for a position, please visit www.healthcore.com.EOE/M/F/Disability/Veteran