100% REMOTE POSITION
TELECOMMUTE
Clinical Research Associate - Remote
Position Overview
Laboratory Express Diagnostics is seeking an experienced Clinical Research Associate (CRA) to join our Research team in a 100% remote capacity. You will monitor clinical trials across multiple sites, ensure regulatory compliance, and serve as the critical link between study sites and sponsors while working from the comfort of your home.
Key Responsibilities
- Monitor clinical trial sites to ensure compliance with protocols and regulatory requirements
- Conduct site qualification, initiation, monitoring, and close-out visits
- Review and verify source documents and case report forms (CRFs)
- Ensure adherence to Good Clinical Practice (GCP) and FDA regulations
- Identify and report protocol deviations and adverse events
- Maintain comprehensive monitoring visit reports and documentation
- Provide training and support to site staff on study protocols
- Collaborate with clinical operations, data management, and regulatory teams
- Track study timelines, enrollment, and deliverables
- Participate in site selection and feasibility assessments
Required Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field
- 2+ years of clinical research monitoring experience
- Strong knowledge of GCP, ICH guidelines, and FDA regulations (21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 56)
- Experience with clinical trial management systems (CTMS) and electronic data capture (EDC)
- Excellent attention to detail and organizational skills
- Strong written and verbal communication skills
- Ability to travel up to 50% for site visits
- Valid driver's license and reliable transportation
- Proficiency with Microsoft Office Suite
Preferred Qualifications
- Master's degree in related field
- CCRP (Certified Clinical Research Professional) or CCRA certification
- Experience in Phase I-IV clinical trials
- Therapeutic area expertise (oncology, cardiology, neurology, etc.)
- Multi-site monitoring experience
- Regulatory submission experience
- Foreign language proficiency
Benefits & Perks
- 100% Remote Work - Work from anywhere in the USA
- Competitive Salary - $65,000 - $85,000 annually
- Comprehensive health insurance (Medical, Dental, Vision)
- 401(k) retirement plan with company match
- Professional certification reimbursement (CCRP, CCRA)
- Continuing education opportunities
- Paid time off and holidays
- Home office equipment provided
- Travel expense reimbursement
- Flexible scheduling between site visits
Laboratory Express Diagnostics is an equal opportunity employer committed to diversity and inclusion in the workplace.
