Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Overseeing clinical trial integrity and compliance through site visits and data validation with an accent on protocol adherence and patient safety. Focus on managing site performance, mentoring junior CRAs, and ensuring regulatory compliance with ICH/GCP and FDA standards.

Location: Remote (US only). Ability to travel up to 75% of the time is required.

Salary: $100,000 - $130,000 USD

Company

A leading precision medicine solutions company focused on the discovery and commercialization of healthcare solutions for transplant patients and caregivers.

What you will do

• Conduct and oversee site visits including selection, initiation, interim, and close-out to ensure protocol adherence and data accuracy.
• Collaborate with Principal Investigators and cross-functional teams to drive study success.
• Identify and resolve data collection issues within electronic data capture (EDC) systems and reconcile queries.
• Mentor junior CRAs and provide technical expertise in clinical programming and data validation.
• Lead study team meetings and contribute to protocol development and amendments.
• Ensure timely execution of monitoring reports and facilitate communication across stakeholders.

Requirements

• Bachelor’s degree or higher in biomedical sciences or a related field.
• 5+ years of experience in clinical research within biotech, pharma, medical device, or academia.
• Must be based in the United States.
• Strong knowledge of GCP, FDA regulations, and ISO standards.
• Proficiency in EDC systems and CTMS.
• Ability to travel up to 75% of the time.

Nice to have

• CCRC or CCRA certification.

Culture & Benefits

• Competitive base salary and incentive compensation.
• Comprehensive health and welfare benefits, including a gym reimbursement program.
• 401(k) savings plan match and Employee Stock Purchase Plan.
• Pre-tax commuter benefits.
• Living Donor Employee Recovery Policy providing up to 30 days of paid leave for organ or bone marrow donors.