Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With 100+ employed clinicians and more than 700 teammates in 75+ clinic locations and growing. TOI is changing oncology for the better.
Regulatory Coordinator
This is a fantastic opportunity to join a team of quality-oriented professionals focused on Clinical Research in Cerritos, CA. This is a hybrid position, with 1 day per week WFH currently.
Responsibilities:
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Maintains research practices using Good Clinical Practice (GCP) guidelines.
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Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
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Handle confidential material with judgement and discretion
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E-filing and sorting from DocuSign to Trial folders on G-drive.
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Reviews ICF completion, to verify documentation completed properly.
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Releases ICF due to requests from Study Coordinator.
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Prepares and releases documentation for training for New Amendments, New IB’s, Protocol Letters and or clarifications among other training document preparation.
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Documents research staff and investigators initial participation on trial and releases documents.
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Tracks and logs pending documents efficiently.
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Request Certification for new research staff and Investigators.
Education and Experience:
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Associates Degree or one or more (1+) years experience with regulatory documents.
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Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).
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Demonstrated experience with multi-study and multi-site clinical research activities.
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Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
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Demonstrated knowledge of FDA and Sponsor regulatory requirements.
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Knowledgeable of FDA and QA audit processes.
