Clinical Research Coordinator (CRC)-FT

Job Title: Clinical Research Coordinator (CRC)-FT

Work Location: Harris County, Texas

Summary:

The Clinical Research Coordinator II is responsible for the coordination, organization, and management of clinical trials, ensuring compliance with regulatory standards and study protocols. This role involves direct interaction with research subjects, study documentation, and collaboration with investigators and site leadership.

Responsibilities:

• Gain comprehensive understanding of study protocols and collaborate with investigators and site leadership to ensure readiness prior to study initiation.
• Draft and review source documents for accuracy and clarity, and develop subject recruitment strategies in coordination with relevant staff.
• Coordinate study management activities, including subject screening, enrollment, and scheduling of visits, while maintaining protocol compliance.
• Obtain informed consent from study participants and ensure all regulatory and study documentation is accurate, organized, and confidential.
• Communicate protocol-related issues to management and contribute to the development and review of standard operating procedures as assigned.
• Attend investigator meetings, complete IRB renewals, and maintain records of all IRB and regulatory communications.
• Ensure timely and accurate completion of case report forms, and report and track adverse events in accordance with study protocols.
• Support data integrity and subject safety throughout the study, and perform additional responsibilities as required by organizational needs.

Qualifications:

• High School Diploma or equivalent required; college degree preferred.
• Two (2) to four (4) years of experience or certification as a Clinical Research Coordinator.
• Ability to communicate effectively and collaboratively with providers, co-workers, sponsors, and other stakeholders.
• Knowledge of medical terminology for effective communication with physician offices and laboratory staff.
• Demonstrated initiative and ability to act independently within study protocols and regulatory requirements.
• Adaptability to changing priorities and evolving study requirements.
• Understanding of regulatory requirements, Good Clinical Practices (GCP), and International Conference of Harmonization (ICH) guidelines.
• Excellent interpersonal, written, and verbal communication skills.
• Basic computer proficiency, including Word, Excel, and clinical research applications.

Published Category: Clinical Operations & Development