Clinical Research Coordinator II

Responsibilities

• Screen, enroll, and monitor clinical research study subjects while ensuring protocol and regulatory compliance.
• Perform basic clinical procedures including blood draws (phlebotomy), vital signs, and ECGs.
• Maintain adherence to FDA regulations, ICH guidelines, and Good Clinical Practices (GCP).
• Identify and promptly report adverse events (AEs) and Serious Adverse Events (SAEs) to the Principal Investigator and Sponsor.
• Manage documentation by recording data in real time on e-source documents and resolving data management queries.
• Coordinate study medication inventory, dispensation, and patient compliance.
• Assist with patient recruitment efforts and the creation of recruitment materials.
• Mentor CRC I peers and provide onboarding and day-to-day guidance.
• Review laboratory results and other test results for completeness and alert values.

Requirements

• Minimum of 3 years of experience as a Clinical Research Coordinator.
• Recent phlebotomy experience is required.
• Strong knowledge of Good Clinical Practices (GCP) and FDA regulations.
• Proficiency in clinical trials databases, IVR systems, and Electronic Data Capture (EDC).
• Excellent working knowledge of medical and research terminology.
• Ability to work independently in a fast-paced environment with minimal supervision.
• Strong organizational, prioritization, and leadership skills.

Preferred Qualifications

• Bachelor’s Degree in a related field.
• 1 year of experience specifically as a Care Access Research Clinical Research Coordinator.

Benefits

• 100% employer-paid medical, dental, and vision insurance plan options.
• Paid Time Off (PTO) and company-paid holidays.
• 401(k) Retirement Plan with company match.
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA) with employer contributions.
• Company-paid Short-Term and Long-Term Disability.
• Relocation support provided.

About the Company

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.