Clinical Research Coordinator I

Clinical Research Coordinator, Level 1 (CRC I)

The Clinical Research Coordinator, Level 1 (CRC I) is a research professional responsible for supporting the oversight and compliance of both system-wide and local Shriners Children's (SHC) clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and collaborating with the Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC policies and procedures, hospital regulations, the Code of Federal Regulations, and Good Clinical Practice (GCP) guidelines, when applicable.

The CRC works collaboratively with investigators, research staff, and clinical teams to ethically recruit and consent Shriners Children's vulnerable pediatric research participants and to appropriately collect, manage, and safeguard research data. The CRC serves as a key liaison among research participants, investigators, sponsors, and regulatory bodies to support proper study conduct, subject safety, and the quality and integrity of study data.

• Supports the implementation and conduct of approved research protocols, ensuring studies are performed in compliance with the protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and SHC policies and standards.
• Performs study-specific research activities and/or interventions within the bounds of professional licensure and training.
• Assists with participant recruitment, screening, informed consent/assent, scheduling, and coordination of study visits.
• Coordinates the collection and documentation of research data.
• Maintains regulatory documentation and study records in accordance with institutional policies and sponsor requirements.
• Supports communication and coordination between investigators, sponsors, monitors, and institutional departments involved in research activities.
• Assists investigators with the development and submission of investigator-initiated research protocols and related regulatory documentation.
• Contributes to study progress reports, monitoring visits, audits, and preparation of study results or presentations when applicable.
• Ensures appropriate training and education are completed in order to safely perform study-related procedures and protocol requirements.

• One or more years of relevant research experience, e.g. site management, study management, research regulatory experience, data collection, compliance or other applicable experience.

• Bachelor's degree in Clinical Research, Life Sciences, Public Health, or another healthcare-related field
• Working knowledge of regulations and guidance related to clinical research (e.g., GCP, FDA regulations, IRB requirements)
• Experience coordinating intergroup or multi-site clinical studies
• CCRP or CCRC certification
• 1 or more years of relevant research experience (e.g., study coordination, site management, regulatory submissions, or clinical data management)

The pay range for this position is $31.09 - $46.64/hour. Compensation is determined based on years of relevant experience and departmental equity.