Clinical Research Coordinator

Description:

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.

Requirements:

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