Research Regulatory Coordinator
US-ID-Boise
careers
Req #: 95811
Type: Full-Time
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Overview: At St. Luke's, our team of Research Coordinators pride ourselves on fostering a workplace culture that values diversity, promotes collaboration, and prioritizes employee well-being. We strive to foster an environment that embraces our employees' unique strengths, experiences and perspectives which drives our exceptional, patient-centered care. What You Can Expect: * A strong and engaging leadership team that wants to help you be successful * On-site work * Prepare and submit regulatory documents for a variety of study types, under limited supervision * Manage appropriate databases, websites, and clinical trial management systems * Participate in the creation, implementation, and documentation of study-specific training Minimum Qualifications: * Education: Bachelor's degree * Experience: 2 years' experience Preferred Qualifications: * Previous experience in clinical research or working with regulatory affairs * Strong knowledge of federal policies regulating clinical trials Responsibilities: Under limited Supervision, the Research Regulatory Coordinator 2 supports a dedicated research site and/or therapeutic area and is responsible for coordinating and maintaining documentation for clinical research. * Prepares and submits regulatory documents for all submissions to St. Luke's Research and the IRB of record on behalf of investigators. * Maintains current regulatory documents in accordance with federal and state regulations, as well as institutional policies. * Develops appropriate regulatory reports and associated documentation in accordance with institutional policies, procedures, and study specific processes. * Prepares and maintains safety reports for submission to the IRB and/or sponsor. * Monitors various external websites to access protocol revisions, updates, safety reports etc. * Ensures Principal Investigator and research staff have access to current versions of all study documents and training materials. * Participates in creation, implementation, and documentation of study specific training. * Manages appropriate databases, websites, and clinical trial management systems. * Acts as a liaison with sponsors, research staff, and non-research personnel. * Prepares for and conducts study monitor visits and various audits. * Participates in development of regulatory policies and procedures. * Performs other duties and responsibilities as assigned. Qualifications: * Education: Bachelor's degree. * Experience: 3 year's experience. * Licenses/Certifications: None
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