Senior Clinical Research Associate - Global Trials Lead

CHEManager International; Boston (KY); On-site; USD 85,000 - 130,000; Full time

Job summary

Alira Health is seeking a Clinical Research Associate (CRA) to conduct site monitoring for clinical trials and provide oversight ensuring protocol adherence and quality across sites. You will collaborate with Lead CRAs and Project Managers to address site questions, support recruitment, and oversee training and site-related activities.

Responsibilities include monitoring visits (remote and on-site), budgeting support, development of Monitoring Plans, and ensuring data integrity and regulatory

Qualifications

• Experience building and maintaining professional relationships with Sponsors, Sites and Teams.
• Ability to autonomously manage monitoring activities and travel as needed.
• Knowledge of ICH-GCP and FDA regulations.

Responsibilities

• Provide guidance and oversight to ensure adherence to scope, SOPs, timelines and budget.
• Conduct monitoring visits (remote and on-site) and prepare detailed visit reports.
• Ensure site activities meet protocol, regulatory, and data integrity requirements.
• Coordinate with cross-functional teams to resolve monitoring issues and train site staff.
• Prepare Monitoring Plans and study-specific training materials as required.
• Manage site ethics documents and contract negotiations as needed.
• Provide monthly billing information to finance and support sponsor communications.

Skills

Relationship management

Autonomous monitoring

Education

BS in Biology

BS in Life Sciences

Tools

CTMS

EDC

eTMF

Job description

Alira Health is seeking a Clinical Research Associate (CRA) to conduct site monitoring for clinical trials and provide oversight ensuring protocol adherence and quality across sites. You will collaborate with Lead CRAs and Project Managers to address site questions, support recruitment, and oversee training and site-related activities.

Responsibilities include monitoring visits (remote and on-site), budgeting support, development of Monitoring Plans, and ensuring data integrity and regulatory