Senior Clinical Research Associate In House Site Management Job

Novo Nordisk - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

Merchant Wholesalers, Nondurable Goods

About the position

The Senior Clinical Research Associate (CRA) is responsible for supporting assigned clinical trial sites in compliance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, federal regulations, and Standard Operating Procedures (SOPs). This role involves collaboration with various teams within North America Clinical Trials (NACO) and may include monitoring of clinical sites to ensure adherence to regulatory standards and company protocols.

Responsibilities

• Support assigned clinical trial sites in compliance with GCP and ICH guidelines.
• Monitor assigned sites according to GCP/ICH and Novo Nordisk Inc. SOPs.
• Collaborate with members of the North America Clinical Trials team and other representatives in Clinical Medical Regulatory.
• Participate in internal meetings and contribute to site management strategies.

Requirements

• Bachelor's degree in a relevant field (e.g., life sciences, nursing).
• Experience in clinical research, preferably as a Clinical Research Associate.
• Strong understanding of GCP, ICH guidelines, and federal regulations.
• Excellent communication and interpersonal skills.

Nice-to-haves

• Advanced degree in a relevant field.
• Experience with electronic data capture systems.
• Knowledge of regulatory submissions and clinical trial processes.

Benefits

• Health insurance coverage
• 401(k) retirement plan
• Paid time off and holidays
• Professional development opportunities