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COMPANY DESCRIPTION
Unio Health Partners (UHP) is a highly differentiated physician practice management platform with the goal of transforming care delivery across the Western United States. UHP partners with leading physician practices, creating a cohesive, quality-oriented clinical culture and facilitating best practice sharing across the platform. Our affiliated practices gain access to a broader suite of services, providing a meaningful benefit to both physicians and patients. UHP's best-in-class clinical program covers three sub-specialties (urology, gastroenterology, and radiation oncology) and offers numerous ancillary services, including pathology lab, in-office dispensing, and chronic care management. We are led by a highly accomplished management team and provides a full suite of management services to its affiliated practices. UHP is currently affiliated with 182 providers consisting of 119 physicians and 63 advanced practice providers operating out of 54 locations across Southern, Central, and Northern California.
POSITION SUMMARY
The Regulatory Specialist is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Regulatory Specialist supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the Regulatory Specialist works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
What you will be doing
- Coordinates with Principal Investigator and department to help ensure that clinical research and related activities are performed in accordance with federal regulations and Institution and sponsoring agency policies and procedures.
- Assists the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, and execution of research plan. Maintains documentation of training
- Completes study documentation and maintains study files in accordance with sponsor requirements and Institution policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Reviews and develops a familiarity with the finalized contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff, and any financial terms or conditions.
- Completes, Collects, and Maintains Regulatory documents needed to initiate, and maintain the study and submits to the sponsor / IRB accordingly (e.g., FDA Forms 1572, CVs, etc.).
What you will bring to the team
- Bachelor's degree in a scientific discipline or over 4 years of clinical research experience in a Clinic Setting. Academic setting applicants will be considered based on experience
- Active certification of accreditation (CCRC/CCRP/GCP/ICH)
- 4+ years of clinical research experience in a private practice setting is desired
- Cancer/Urology clinical research experience, preferred
- Experience working with Electronic Data Capturing System, IRB Portals, and IWRS/IXRS
What we can offer you
- Competitive Salary and Health Benefits (Medical, Dental, Vision)
- Generous time off (start accruing on your first day no waiting period)
- Paid Holidays
- 401(k)
- Company Discounts
- Collaborative work environment - we want our employees to have a say in how we run our office
- Employee Recognition - we encourage employee recognition through our GEMS program
Please note that actual pay will be determined based on the relevant experience and internal equity within the pay range.
