Position Summary
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator (CRC) to oversee and manage clinical trials from start-up through close-out. This role requires strong organizational skills, regulatory knowledge, and the ability to work closely with patients, investigators, sponsors, and coordinate activities across both on-site and remote PRN staff. Candidates must be willing to travel, including attendance at Investigator Meetings (IMs), as required. This is not an entry-level role and requires a high level of accountability, ownership, and the ability to operate independently with minimal oversight.
Key Responsibilities
- Independently coordinate multiple clinical trials from startup to close-out
- Lead patient recruitment, screening, consenting, and retention strategies
- Conduct study visits, assessments, and protocol-specific procedures
- Ensure strict adherence to GCP, FDA regulations, and protocol requirements
- Maintain high-quality source documentation and EDC data entry (real-time, audit-ready)
- Manage investigational product accountability and study logistics
- Serve as the primary point of contact for sponsors, CROs, and monitors
- Prepare for and confidently support monitoring visits, audits, and FDA inspections
- Identify inefficiencies and proactively improve workflows
Performance Expectations
- Maintain audit-ready documentation at all times (ALCOA+ compliant)
- Ensure timely and accurate EDC data entry (real-time or within defined timelines)
- Demonstrate ownership of assigned studies with minimal oversight
- Maintain readiness for monitoring visits, audits, and FDA inspections at all times
- Proactively identify, document, and escalate issues, risks, and protocol deviations
Work Environment
- Fast-paced, high-accountability clinical research setting
- Requires ability to manage competing priorities and adapt to changing study demands
- High level of autonomy with expectation of independent problem-solving
Qualifications
- Bachelor’s degree in life sciences, healthcare, or related field (preferred)
- 2+ years of clinical research experience (CRC experience preferred)
- Strong knowledge of GCP, FDA, and IRB processes
- Experience with EDC systems and clinical trial documentation
- Excellent organizational, communication, and multitasking skills
- Ability to manage multiple studies in a fast-paced environment
Highly Preferred (but not required)
- Experience in neurology, neuromuscular, or rare disease trials
- Experience in industry-sponsored trials
- Phlebotomy and/or clinical skills
- Certification (CCRC, CCRP, or equivalent)
- Experience in reviewing patient medical records for pre-screening
- Experience with CRIO preferred but not required
Compensation & Benefits
- Competitive salary (based on experience; typical CRC range (~$50K–$70K/year)
- Health, dental, and vision insurance
- Paid time off
- Opportunities for growth and leadership within a rapidly expanding research center
Company Description
Neurology Rare Disease Center is a growing neurology and clinical research center dedicated to advancing care for patients with rare neuromuscular diseases. We are committed to high-quality, patient-centered research and innovation. We are building a team of people who care deeply about patients and take pride in doing things the right way.