Clinical Research Coordinator

This is an on-site role. Candidates must be local to Charleston, WV. Relocation assistance is not available.

We are seeking an experienced Clinical Research Coordinator (CRC) to independently manage and execute clinical trials at the site level. This role is responsible for overseeing day-to-day study operations, regulatory compliance, patient coordination, and data management in accordance with protocol, GCP guidelines, and internal SOPs.

Job Purpose:

• Coordinate research and administrative procedures for the successful management of clinical trials
• Ensure SOPs are followed
• Perform diverse administrative duties pertaining to clinical research
• Manage trial operations

Essential Functions/Responsibilities (other duties may be assigned):

• Independently manage clinical trial operations from start-up through closeout
• Ensure compliance with protocols, GCP, IRB, and regulatory requirements
• Coordinate with investigators, sponsors, CROs, and IRB
• Screen, consent, and enroll study participants
• Maintain accurate and timely source documentation, CRFs, and regulatory files
• Enter and manage data in EDC systems and CTMS
• Track subject enrollment, retention, and follow-ups
• Report adverse events (AEs/SAEs) within required timelines
• Prepare for and support monitoring visits, audits, and inspections
• Manage study supplies, equipment, and investigational product (IP)
• Maintain regulatory binders and study documentation in audit-ready condition

Required Skills and Experience:

• Minimum 2+ years of Clinical Research Coordinator (CRC) experience at a site level
• Hands-on experience with:
  • EDC systems (e.g., Medidata, REDCap, etc.)
  • IRB submissions (initial, continuing review, closures)
  • Informed consent process
  • Adverse event reporting
• Strong understanding of:
  • Good Clinical Practice (GCP)
  • FDA and regulatory guidelines
• Experience managing multiple studies simultaneously
• Ability to work independently with minimal supervision
• Strong attention to detail and documentation accuracy

Preferred Qualifications:

• Bachelor’s degree in Life Sciences, Healthcare, or related field
• Experience with CTMS systems
• Current GCP certification

What Will Set You Apart

• Experience working directly with sponsors/CROs
• Ability to manage full study lifecycle
• Strong organizational and problem-solving skills in a fast-paced environment

Benefits Offered:

• Health Insurance (Single & Family plans available)
• Life Insurance
• Disability Insurance
• 401(k) Plan with Company Match
• Employee Discount Program
• Paid Time Off
• Paid Holidays