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| The Regulatory Coordinator works closely with principal investigators and study coordinators to coordinate study specific regulatory documentation that ensure compliance with regulatory requirements. Working under general supervision, this position supports grant funded research and/or industry sponsored clinical research by performing a variety of duties involved in the collection, submission and processing of regulatory documents. |
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Serves as a liaison between the Institutional Review Board (IRB) office and research staff, internal/external regulatory and oversight groups, and government agencies, ensuring effective communication and collaboration in the hospital/medical group industry.
Coordinates and guides the review and approval process of all research activities associated with clinical research studies, facilitating the timely initiation of research projects while ensuring compliance with regulatory requirements.
Maintains protocol books and regulatory binders, organizing essential study documents and ensuring the accuracy and completeness of regulatory records, supporting efficient and compliant research operations.
Provides database support, including maintenance of research logging and tracking databases, electronic filing systems, and preparation of quarterly reports reflecting research approvals and accomplishments, contributing to streamlined data management and accurate reporting of research activities.
Leads, coordinates, and performs study specific regulatory documentation across multiple studies of different therapeutic areas and phases.
Performs other duties as assigned. |
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| EDUCATION: |
| Required: Associates degree |
| EXPERIENCE: |
| Required: 2 years' experience, preferably in office management/project management or clinical research |
| LICENSURE/CERTIFICATION/REGISTRY/LISTING: |
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Equal Opportunity Employer At Cone Health, we strive to create a welcoming atmosphere that celebrates a diverse and unique workforce. We believe in offering equal opportunities for employment to all applicants and employees, regardless of their race, religion, age, sex, sexual orientation, gender identity, veteran's status, ethnicity, national origin, disability, color, or any other characteristic protected by law. Our hiring and employment choices are based on each individual's qualifications, skills and performance. We believe that by embracing the diversity of our team, we can better serve our patients, communities and each other.
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Cone Health
Jan 17, 2025