Lead Clinical Research Associate - Remote

Overview

The Lead Clinical Research Associate (LCRA) at Scholar Rock will oversee monitoring activities and ensure compliance with clinical trial protocols in collaboration with Clinical Trial Managers and CROs.

In Short

• Serve as a representative of Scholar Rock to CROs and study sites.
• Create and ensure adequate training for CRO CRAs.
• Review Monitoring Visit Reports from CROs.
• Monitor studies and perform co-monitoring visits as needed.
• Develop metrics to evaluate CRO CRAs and site performance.
• Maintain the Trial Master File in an inspection-ready state.
• Oversee study site setup and activation activities.
• Assist in the review of informed consent forms and essential documents.
• Participate in investigator meetings and assist with planning.
• Travel, including international travel, is required.

Requirements

• BS/BA degree in a scientific discipline; advanced degree preferred.
• Minimum of 3 years site monitoring experience in a biotech, pharmaceutical, or CRO setting.
• Highly organized and outcome-oriented.
• Excellent interpersonal and negotiation skills.
• Knowledge of Electronic Data Capture and IT systems.
• Ability to analyze complex issues and develop realistic plans.
• Good understanding of clinical research and GCP/ICH guidelines.
• Strong written and oral communication skills.
• Certification as a Clinical Research Associate or Professional is desirable.

Benefits

• Opportunity to work in a leading biopharmaceutical company.
• Engagement in innovative therapeutic approaches.
• Collaboration with a team of experienced professionals.
• Potential for career growth and development.
• Flexible working environment.