CLINICAL RESEARCH COORDINATOR in Charleston, South Carolina at StrideCare

Job Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of clinical research studies at the assigned StrideCare site. Working under the supervision of the Principal Investigator (PI) and in collaboration with Clinical Operations leadership, the CRC ensures compliance with study protocols, FDA regulations, ICH Good Clinical Practice (GCP) guidelines, sponsor requirements, and organizational standards while supporting participant safety and study success.

Supervisory Responsibilities: N/A

Essential Duties / Responsibilities:

• Screen patients for study enrollment and eligibility.
• Conduct and document patient consent activities.
• Coordinate patient follow-up visits and study schedules.
• Document study activities in source documents and clinic charts.
• Enter data into EDC systems and resolve study queries.
• Obtain vital signs and ECGs per protocol requirements.
• Perform basic laboratory procedures including specimen collection, processing, storage, shipment, and accountability.
• Request and track medical records.
• Maintain study logs, regulatory files, and chart documentation.
• Maintain and order study-specific supplies.
• Schedule study participants and conduct appointment reminders.
• Build and update source documentation as needed.
• Coordinate monitoring visits and resolve findings in a timely manner.
• Ensure study reports and patient results are reviewed by the Investigator.
• File SAE and protocol deviation reports with Sponsors and IRBs as required.
• Document and report adverse events and safety concerns.
• Report non-compliance concerns to appropriate personnel.
• Maintain positive communication with sponsors, monitors, participants, investigators, and team members.
• Adhere to ALCOA-C documentation principles.
• Assist with recruitment, enrollment, and participant tracking activities.
• Complete study start-up activities, training requirements, and regulatory documentation.
• Prepare for and participate in Site Initiation Visits (SIVs) and Investigator Meetings (IMs).
• Assist with setup and maintenance of study-related technology.
• Perform other duties as assigned.

Required Skills / Abilities:

• Proficiency with Microsoft Office applications, email, EHR/EMR systems, and web-based applications.
• Accurate data entry and typing proficiency.
• Ability to perform vital signs, ECGs, phlebotomy, and other basic clinical procedures.
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Strong interpersonal and active listening skills.
• Ability to work independently and collaboratively with investigators, participants, sponsors, and team members.
• Ability to manage multiple priorities and adapt to changing workloads.
• Professional demeanor, dependability, and strong work ethic.
• High degree of integrity and confidentiality.
• Strong problem-solving and critical-thinking abilities.
• Ability to handle sensitive information in compliance with HIPAA requirements.

Education and Experience:

• Medical Assistant diploma, LPN/LVN credential, EMT credential, Associate degree, or equivalent combination of education and experience required.
• Minimum one year of clinical research or clinical healthcare experience preferred.
• Experience with phlebotomy, vital signs, ECGs, specimen handling, and clinical documentation preferred.
• Current GCP certification or ability to obtain certification required.
• Bilingual English/Spanish skills are a plus.

*StrideCare is an Equal Opportunity Employer and is committed to diversity and inclusion in our workforce. We encourage applications from candidates of all backgrounds and experiences.