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Clinical Research Coordinator/Specialist
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The Clinical Research Coordinator/Specialist is responsible for the overall implementation of assigned research protocols, ensuring efficiency and regulatory compliance.
Key Responsibilities- Coordinate clinical trials research team activities and report to the Clinical Research Manager and Principal Investigators.
- Collect, record, and maintain complete data files using good clinical practice and HIPAA regulations.
- Participate in data retrieval, reporting, and preparation of files and Case Report Forms.
- Interact with subjects, scheduling diagnostic and research evaluation visits, and perform study-related assessments.
- Maintain study supplies and equipment, and oversee subject compliance to the study protocol.
- Protect the rights, safety, and well-being of human subjects involved in clinical trials.
- Coordinate collection of study specimens and processing, and collect and manage patient and laboratory data.
- Manage research project databases, develop flow sheets, and complete study documents/case report forms.
- Ensure compliance with research protocols, review and audit case report forms, and prepare regulatory submissions.
- 1+ years of Clinical Research Coordinator experience.
- Spanish speaking preferred.
- Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
- Proficiency with Microsoft Office and knowledge of medical terminology.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.
Occasional evening and weekend hours. Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.