Clinical Research Associate – Migraine Clinical Trial

Role Overview

We are seeking an experienced Clinical Research Associate (CRA) to support Phase II–III studies focused on migraine. This opportunity is with a rapidly expanding Contract Research Organization (CRO) dedicated to advancing innovative therapies for migraine patients.

Key Responsibilities

• Manage clinical trial sites independently throughout all phases including site initiation visits (SIVs), interim monitoring visits (IMVs), close-out visits (COVs), and remote assessments.
• Perform thorough source data review and verification, safety assessments, regulatory document management, and ensure protocol adherence.
• Implement risk-based monitoring (RBM) approaches to detect site-related risks, data inconsistencies, recruitment difficulties, and quality concerns.
• Foster strong collaborative relationships with investigators, site personnel, sponsors, and other cross-functional teams.
• Maintain strict compliance with ICH-GCP guidelines, FDA regulations, clinical protocols, and sponsor expectations.

Required Qualifications

• A minimum of 3 years of independent clinical monitoring experience within CROs, biotech, pharmaceutical, or medical device environments.
• Proven ability to manage multiple investigative sites autonomously.
• Comprehensive understanding of clinical trial operations, trial monitoring processes, and regulatory landscapes.
• Strong communication skills paired with willingness and ability to travel approximately 70% within the United States.

Why This Position?

• Join a dynamic and expanding CRO with engaging clinical projects.
• Contribute to impactful migraine research fostering patient-centered innovation.
• Collaborate with an experienced and supportive clinical operations team.
• Access competitive remuneration and professional growth opportunities.