What are the responsibilities and job description for the Lead Regulatory Coordinator - The Angeles Clinic & Research Institute position at Cedars-Sinai Health System?
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The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.
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The Lead Regulatory Coordinator prepares and submits large and/or complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role evaluates and works to improve the operational workflow by establishing priorities and delegating tasks within the unit.
Primary Duties and Responsibilities:
- Prepares and submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
- Advises and directs the regulatory documentation workflow within the unit as well as provides consultation to staff engaging in new clinical trials.
- Develops and governs the standard operation procedures in order to achieve consistent results.
- Develops and trains internal and external customers on regulatory workflows.
- Leads the implementation of new applications and/or systems within the unit.
- Responds to escalated data requests and questions.
- Leads cross functional meetings and provides updates on the status of all regulatory submissions.
- Coordinates site qualification visits with industry sponsors.
- Identifies quality and performance improvement opportunities and provides recommendations to improve operational efficiency within the unit.
Job Info
Salary : $72,155