Clinical Research Coordinator in Katy, Texas at HOUSTON REGIONAL GASTROENTEROLOGY INSTITUTE PLLC

The Clinical Research Coordinator is responsible for overseeing the daily activities required to maintain clinical research site compliance with ICH-GCP guidelines and internal standards. This role requires the ability to independently manage up to five active study protocols simultaneously while ensuring high-quality study execution and regulatory compliance. The ideal candidate is detail-oriented, organized, and possesses strong interpersonal and leadership skills.

Key Responsibilities, duties include, but are not limited to:

• Manage multiple clinical research protocols simultaneously
• Oversee study start-up, enrollment, monitoring visits, and close-out activities for assigned studies
• Maintain regulatory documentation and ensure compliance for assigned studies
• Coordinate study-related procedures and patient visits
• Perform patient assessments, including collection of vital signs and EKGs
• Collect, process, and manage biological samples
• Complete accurate and timely data entry
• Coordinate patient scheduling and follow-up activities
• Support patient recruitment and retention efforts
• Maintain and calibrate research equipment as needed
• Assist with start-up activities for new research sites, including:
  • Ordering equipment
  • Training site staff
  • Ensuring research space meets operational requirements
• Provide training and mentorship to staff, as applicable
• Potentially supervise staff at assigned research sites, including:
  • Managing daily workflow and task delegation
  • Monitoring productivity and efficiency
  • Addressing and resolving interpersonal or operational issues

  Qualifications & Skills

• Strong organizational and multitasking abilities
• Excellent communication and interpersonal skills
• High attention to detail and commitment to regulatory compliance
• Ability to work independently and collaboratively in a fast-paced environment
• Prior clinical research coordination experience required