Clinical Research Coordinator II

Responsibilities

• Screen, enroll, and monitor clinical research study subjects while ensuring protocol and regulatory compliance.
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
• Perform basic clinical procedures including blood draws (phlebotomy), vital signs, and ECGs.
• 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 and attend site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives.
• Assist with patient recruitment efforts, including planning materials and contacting potential candidates.
• Mentor CRC I peers and provide day-to-day guidance and onboarding support.

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).
• Ability to work independently in a fast-paced environment with minimal supervision.
• Excellent professional writing and verbal communication skills.

Preferred Qualifications

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

Benefits

• Paid Time Off (PTO) and Company Paid Holidays.
• 100% employer-paid medical, dental, and vision insurance options.
• 401(k) Retirement Plan with Company Match.
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA).
• 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.