Clinical Research Regulatory Coordinator
510 Superior Ave. Newport Beach, CA 92663 US
**salary will be commensurate with experience**
The Clinical Research Regulatory Coordinator will support clinical research teams (physicians, nurses, etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Will be responsible for ensuring that all research studies are compliant with regulations as well as maintain accurate and up-to-date regulatory files. Will serve as a central resource for staff conducting clinical research. This position reports to the Director, Clinical Research. Essential Functions:
• Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
• Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
• Remains informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
• Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
• Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
• Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.
• Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
• Reviews and complete CDAs for new studies; assists with assigning study codes.
• Works with external researchers to complete External Visitors Checklist to meet badge requirements for access to institution.
• Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.
• Works with multiple IRBs and understands their submission process and requirements. Provides institutional authorization for new submissions with WIRB. Communicates and maintains working relationship with WIRB to ensure institutional needs met per Master Services Agreement.
• Provides study, enrollment updates and SAE reports to Clinical Research Oversight Committee.
• Work with Investigators to renew NCI/CTEP applications.
• Participates in required teleconferences, on-site meetings and off-site investigator meetings, as required.
• Maintains working knowledge of current protocols and internal SOPs.
• Excellent communication skills and superb attention to detail.
• Excellent inter-personal skills and customer service focus is required.
• Strong writing and organizational skills.
• Able to work in a fast-paced environment with flexibility and autonomy.
• Must be able to prioritize tasks on a daily basis.
• Computer knowledge in Microsoft windows applications including Word, Outlook and Excel and familiarity with electronic data capture systems preferred.
• Associates degree or equivalent education required.
• One (1) year of experience in the field of regulatory documentation management or clinical research required.
• Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
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