Regulatory Coordinator - Oncology Clinical Research

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:  

• Maintains research practices using Good Clinical Practice (GCP) guidelines.  
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.  
• Handle confidential material with judgement and discretion  
• E-filing and sorting from DocuSign to Trial folders on G-drive.  
• Reviews ICF completion, to verify documentation completed properly.  
• Releases ICF due to requests from Study Coordinator.  
• Prepares and releases documentation for training for New Amendments, New IB’s, Protocol Letters and or clarifications among other training document preparation.  
• Documents research staff and investigators initial participation on trial and releases documents.  
• Tracks and logs pending documents efficiently.  
• Request Certification for new research staff and Investigators.  

Education and Experience: 

• Associates Degree or one or more (1+) years experience with regulatory documents.  
• Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).  

• Demonstrated experience with multi-study and multi-site clinical research activities.  
• Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.  
• Demonstrated knowledge of FDA and Sponsor regulatory requirements.  
• Knowledgeable of FDA and QA audit processes.