Clinical Research CoordinatorFoot and Ankle Specialists • Charleston, South Carolina, United States
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Clinical Research Coordinator
Foot and Ankle Specialists
- Charleston, South Carolina, United States
- Charleston, South Carolina, United States
Über
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
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Sprachkenntnisse
- English
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