CLINICAL RESEARCH ASSOCIATE 2, MEDICAL DEVICE - IQVIA MEDTECH

$71,900 - $189,000/Yr

IQVIA - Durham, NC

Part-time - Mid Level

Durham, NC

Professional, Scientific, and Technical Services

About the position

The Clinical Research Associate II at IQVIA MedTech is responsible for monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. This role involves performing site visits, training site staff, and managing study progress to enhance subject recruitment and data integrity.

Responsibilities

• Perform site monitoring visits including selection, initiation, monitoring, and close-out visits according to regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Work with sites to adapt and track subject recruitment plans to meet project needs.
• Administer protocol and study training to assigned sites and maintain communication to manage project expectations.
• Evaluate the quality and integrity of site practices and escalate quality issues as necessary.
• Manage the progress of assigned studies by tracking regulatory submissions, recruitment, and data query resolution.
• Ensure site documents are available for filing in the Trial Master File (TMF) and maintain the Investigator's Site File (ISF).
• Create and maintain documentation regarding site management and monitoring visit findings.
• Collaborate with study team members for project execution support.

Requirements

• Bachelor's Degree in a scientific discipline or healthcare preferred.
• At least 1 year of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Experience monitoring Medical Device trials.

Nice-to-haves

• Experience with Central Nervous System (CNS) studies.

Benefits

• Competitive salary range of $71,900.00 - $189,000.00 based on qualifications and experience.
• Incentive plans, bonuses, and other forms of compensation may be offered.
• Health and welfare benefits.