Clinical Research Associate (CRA) - Remote

Overview

MCRA, an IQVIA business, is seeking a Clinical Research Associate to be a critical member of the clinical operations team, responsible for management of assigned investigator sites and all monitoring activities for assigned studies.

In Short

• Ensure monitoring activities are completed in accordance with SOPs and Clinical Monitoring Plan.
• Conduct on-site and remote study monitoring and site management.
• Assist project manager with clinical study planning and management.
• Draft protocol-specific manuals and documents as needed.
• Develop and maintain positive relationships with clients and site personnel.
• Assist in the identification and recruitment of potential investigators.
• Verify site qualifications for clinical studies.
• Ensure Trial Master File is accurate and complete.
• Prepare and conduct site training for clinical trials.
• Maintain knowledge of GCP and FDA guidance.

Requirements

• Bachelor's degree in life sciences or related field or Registered Nurse/Allied Health Professional.
• 2+ years of clinical research experience required.
• Minimum of 1 year of direct clinical trial monitoring experience.
• Medical device experience is a plus.
• Knowledge of ICH guidelines for GCP.
• Experience using EDC and clinical trial management systems.
• Strong written and verbal communication skills.
• Strong analytical and problem-solving skills.
• Proficiency with MS Office Suite.
• Ability to communicate in English.

Benefits

• Travel (75%) required for this position.