Senior Clinical Research Coordinator - On-Site Denton, TX

Revival-Research-Institute,-LL; Richardson (TX); Presencial; USD 60 000 - 85 000; Tempo integral

Resumo da oferta

Revival Research Institute seeks an experienced Clinical Research Coordinator to independently run industry-sponsored interventional trials from site initiation through close-out, on-site in Denton, Texas.

The role involves screening, enrollment, regulatory management, and data entry into EDC, with ongoing sponsor and IRB communication, IP accountability, and adherence to HIPAA and ICH-GCP standards.

Qualificações

• 2+ years as a Clinical Research Coordinator on industry-sponsored interventional trials.
• Experience obtaining informed consent on interventional protocols.
• Hands-on experience with EDC platforms.
• Experience hosting monitoring visits and resolving monitoring findings independently.
• Working knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
• Phlebotomy competency and IV certification preferred.
• Ability to work on-site in Denton, Texas.
• Proficiency with Microsoft Office; strong verbal and written communication.
• Master's degree in a health-related field, or equivalent clinical research site experience.

Responsabilidades

• Screen, recruit, and enroll participants per protocol.
• Obtain informed consent following ICH-GCP and 21 CFR Part 50.
• Manage regulatory binders and trial documents across the study lifecycle.
• Coordinate data entry into sponsor-specified EDC timelines and resolve queries.
• Communicate with sponsors, CRAs, central labs, and vendors.
• Oversee IP receipt, dispensing, reconciliation, and storage conditions.
• Maintain inspection-ready files and ensure quality control in the study.

Conhecimentos

Verbal and written communication

Independent work

Attention to detail

Time management

Formação académica

Master's degree in a health-related field

Ferramentas

EDC platforms

HIPAA-compliant systems

Descrição da oferta de emprego

Revival Research Institute seeks an experienced Clinical Research Coordinator to independently run industry-sponsored interventional trials from site initiation through close-out, on-site in Denton, Texas.

The role involves screening, enrollment, regulatory management, and data entry into EDC, with ongoing sponsor and IRB communication, IP accountability, and adherence to HIPAA and ICH-GCP standards.