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Clinical Research Regulatory Specialist
2 months ago
The University of California's Department of OBGYN is in search of a dedicated Clinical Research Coordinator to oversee the regulatory aspects of intricate clinical trials. This position entails conducting thorough evaluations of clinical research protocols and leveraging that information to prepare, manage, and submit all necessary study and regulatory documentation, as well as applications and forms required by internal university policies, FDA standards, and sponsor obligations.
In this role, you will collaborate with study monitors to efficiently process, review, and gather the essential regulatory documents, ensuring compliance with federal, state, and university regulations.
Key Responsibilities:- Conduct detailed reviews of clinical research protocols.
- Prepare and manage all regulatory submissions and applications.
- Work closely with study monitors to ensure timely collection of regulatory documents.
- Maintain compliance with all applicable laws and regulations.
Required:
- At least 3 years of experience in clinical research coordination.
- Strong interpersonal skills for effective communication and relationship building.
- Ability to prioritize tasks and manage competing deadlines.
- Analytical skills for assessing protocols and regulatory requirements.
- Meticulous attention to detail in a dynamic work environment.
- Organizational skills for maintaining regulatory files and balancing tasks.
- Proficiency in Adobe and Microsoft Office Suite, particularly Excel.
- A proactive approach to learning new software and processes.
- Knowledge of clinical research concepts and human safety regulations.
- Experience with various IRBs and research committees.
Preferred:
- Bachelor's degree in a relevant field.
