Jobs in South Plainfield, NJ

About the role

The Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Client's drug pipeline. This position will report to Associate Director of Clinical Operations and be responsible for operational support for clinical studies and related activities in accordance with company standard operating procedures, good clinical practice, and applicable regulatory requirements.

What you'll bring

• Support project management oversight of Clinical Development activities for multiple domestic and international trials, including:
• Track study timelines
• Review and track study budgets
• Provide periodic updates on Clinical Development
• Gradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data management
• Provide monitoring support, in some cases functioning as the primary site monitor.
• Assist in writing and review of protocols, amendments, and informed consent forms.
• Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
• Collaborate with Quality Assurance Department in development of Clinical Development standard operating procedures (SOP).
• Perform investigative site training
• Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams.
• Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed.