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 800 teammates in 60+ clinic locations and growing. TOI is changing oncology for the better.
Senior Regulatory Coordinator
Responsibilities:
- Serve as the Regulatory Manager in the absence of the acting manager
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Assists with auditing trials (Review and Preparation)
- Reviews and Submits Protocol Deviations and SAEs to IRB.
- Works directly with monitor and completes requests.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
- Multi-task and prioritize effectively
- Organize multiple projects for efficiency
- Work efficiently and complete tasks with a high degree of accuracy
- Review IRB Portals for new approvals.
- File and maintain reg binder/e-Reg.
- Review DocuSign Portal and e-File documents.
- Prepare and complete the release of IND Safety reports for several trials.
- Assist in FDA and Sponsor Audits
Skills & Abilities:
- Knowledgeable of FDA and QA audit processes.
- Strong interpersonal communication skills to interact with others effectively and diplomatically.
- Strong written communication skills, ability to compose correspondence and maintain large file system.
- Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).
Education and Experience:
- Four or more (4+) years experience with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed.
- 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.
- Bachelor’s Degree preferred
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.
