Senior Clinical Research Associate

Summary

Join MCRA, an IQVIA business, as a Senior Clinical Research Associate and become a key member of the clinical operations team. You will manage investigator sites and monitoring activities for assigned studies, ensuring compliance with GCP guidelines and SOPs. This role requires strong clinical research experience, knowledge of ICH guidelines, and proficiency in EDC and clinical trial management systems. The position involves significant travel (approximately 75%) and is based in NY or NJ. A competitive salary between $100,000 and $120,000 per year is offered. MCRA values its employees and provides a dynamic work environment within a leading medical device advisory firm and CRO.

Requirements

• Bachelor's degree (B.A./B.S.) in life sciences, healthcare or a related scientific discipline or Registered Nurse/Allied Health Professional with clinical research experience
• 4-5+ years of direct, on-site clinical trial monitoring experience required
• Knowledge of ICH guidelines for GCP
• Knowledge of clinical monitoring procedures and best practices
• Experience using Electronic Data Capture (EDC) and clinical trial management systems
• Strong written and verbal communication and presentation skills
• Strong research, analytical, critical-thinking, and problem-solving skills
• Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
• Ability to read, write, speak, and understand English
• Travel required: approximately 75%
• Location: based in NY or NJ

Responsibilities

• Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan
• Conduct on-site and remote study monitoring and site management
• Assist project manager with clinical study planning and management, as required
• Assist Clinical Trial Manager with drafting protocol-specific manuals, plans, and documents as needed
• Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
• Assist in the identification and recruitment of potential investigators and study sites
• Verify site qualifications and capabilities to conduct clinical studies
• Assist Clinical Trial Manager and In-House CRA with ensuring that Trial Master File is accurate and complete throughout the lifecycle of the project
• Prepare and conduct site and CRA training for assigned clinical trials
• Assist with site audits and site quality management activities as needed
• Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current developments in the assigned therapeutic areas
• Assist with professional development for Clinical Research Associates and Clinical Trial Associates

Preferred Qualifications

Medical device experience is a plus

Benefits

$100,000 - $120,000 a year