Regulatory Coordinator - Oncology Clinical Research - The Oncology Institute of Hope and Innovation
Cerritos, CA
About the Job
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.
The estimate displayed represents the typical wage range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role.
