Clinical Research Study Associate-PS4573

Anthem, Inc. - Wilmington, DE (30+ days ago)3.8

HealthCore, Inc., a health services research firm headquartered in Wilmington, DE is seeking Late Phase Clinical Study Associates and Sr. Clinical Study Associates to join our dynamic company. 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.

We are currently seeking entry-level and experienced Clinical Study Associates (CSAs) to join the team in our Wilmington, DE; Andover or Watertown, MA locations. The primary role of the CSA is to manage sites participating in HealthCore late phase research studies, including, but not limited to Pragmatic Clinical Trials (PCTs), Post-Authorization Safety Studies (PASS), and Disease or Product Registries.

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. Qualifications:

BS degree in a life sciences field or relevant education and/or equivalent training in health services research, or a related field and 1-3 years of experience (3+ years for Sr. level) including clinical research. Experience as a CRC is a plus.

Excellent oral and written communication skills are essential.

Requires 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 An Equal Opportunity Employer/Disability/Veteran