Clinical Research Associate - Sponsor Dedicated (Medical Device)

IQVIA • Parsippany-Troy Hills, NJ

410d • $73,780 - $174,468

About The Position

The Clinical Research Associate (CRA) - Sponsor Dedicated role at IQVIA involves monitoring and managing clinical trial sites for medical devices. The position focuses on ensuring compliance with regulatory requirements, driving subject recruitment, and maintaining high-quality study practices. The CRA will collaborate with study teams, mentor clinical staff, and handle site financial management, all while contributing to the advancement of innovative medical treatments.

Requirements

• Bachelor's Degree in a scientific discipline or health care preferred.
• At least 11 months of on-site monitoring experience required.
• Expert knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops and mobile devices.
• Excellent communication skills, both written and verbal, with a good command of the English language.
• Outstanding organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to build and maintain effective relationships with coworkers, managers, and clients.

Responsibilities

• Embark on site monitoring adventures including selection, initiation, monitoring, and close-out visits in line with regulatory requirements.
• Drive and track subject recruitment plans with sites to meet project needs.
• Lead protocol and study training sessions for assigned sites, establishing strong communication channels.
• Evaluate and ensure the highest quality of study site practices, maintaining strict adherence to protocols and regulations.
• Oversee the progress of studies by tracking regulatory submissions, approvals, recruitment, enrollment, and data query resolution.
• Maintain meticulous documentation for the Trial Master File (TMF) and verify the Investigator's Site File (ISF).
• Create comprehensive reports on site management, monitoring visit findings, and action plans.
• Mentor and inspire clinical staff through co-monitoring and training visits.
• Collaborate with study team members to support project execution and ensure success.
• Handle site financial management according to clinical trial agreements.

Benefits

• Health insurance
• 401k
• Paid holidays
• Professional development opportunities
• Flexible scheduling

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree