Clinical Research Coordinator

Medical University of South CarolinaColumbia, SC
19d

About The Position

The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required.

Requirements

  • Bachelor’s degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required.
  • Working knowledge of GCP, FDA regulations, and clinical trial operations
  • Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP)
  • Excellent communication, organization, and interpersonal skills
  • Ability to collect, organize and analyze information in a clear and concise manner
  • Proficiency with EDC systems, Microsoft Office Suite, and medical terminology

Nice To Haves

  • Minimum 1–2 years of experience in clinical research coordination preferred
  • Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study)
  • Laboratory or phlebotomy experience is preferred but not required
  • Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus

Responsibilities

  • Study Coordination & Execution Coordinate day-to-day operations of assigned clinical trials, including subject recruitment, scheduling, and visit management.
  • Regulatory Compliance & Documentation Prepare and maintain IRB submissions, regulatory binders, informed consent documents, and other essential documents. Ensure compliance with FDA, GCP, ICH, and institutional policies.
  • Data Collection & Management Collect, enter, and review study data in case report forms (CRFs) or electronic data capture (EDC) systems. Perform data queries and ensure accuracy and completeness.
  • Participant Interaction & Informed Consent Conduct informed consent discussions and maintain ongoing communication with participants throughout the study to ensure adherence and safety.
  • Sponsor & Monitor Communication Liaise with sponsors, CROs, and monitors during site initiation, monitoring visits, and close-outs. Ensure timely query resolution and protocol adherence.
  • Training & Education Stay current with regulatory requirements and clinical research practices. Participate in ongoing training and continuing education. May assist in training new staff.
  • Budget & Financial Tracking Support budget development and track participant stipends and study-related billing. Communicate with finance teams as needed.
  • Other Duties as Required Other duties as assigned
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