Research Regulatory Affairs Associate

4 weeks ago

Phoenix, United States Banner Health Full time

**Primary City/State**:
Phoenix, Arizona

**Department Name**:
Facility Research Personnel

**Work Shift**:
Day

**Job Category**:
Research

Good health care is key to a good life. At Banner Health, we understand that, and that’s why we work hard every day to make a difference in people’s lives. Do you like the idea of making a positive change in people’s lives - and your own? If so, this could be the perfect opportunity for you.

Banner Research is currently seeking a **Research Regulatory Affairs Associate** to assist with providing regulatory support for facility-based research. All clinical research studies have a myriad of regulatory documents and required submissions. Failure to maintain required documentation and IRB approvals would result in non-compliance with federal regulations. As a facility-based Research Regulatory Affairs Associate, you will provide regulatory support for a variety of types of projects, such as clinical trials, investigator-initiated studies, cooperative studies, chart reviews, and more. Our portfolio includes multiple research areas, such as cardiovascular disease, orthopedics, neurology, pediatrics, pharmacy, and many others. **We provide research regulatory support for many of the Banner hospitals and other facilities where research is taking place in multiple states**.

As a **Research Regulatory Affairs Associate** you will work closely with clinicians, coordinators, and other site staff while maintaining an electronic Investigator Site File for all studies. In a typical day, you may assist in making sure documents meet IRB specifications and submit to the IRB, collect and update regulatory documents, and interact with various stakeholders. Every day is different, so an interest in learning about multiple types of studies is a plus. You should be able to stay very organized while multitasking, meeting deadlines, prioritizing your workload, and feel comfortable using online and Microsoft programs. Critical thinking and attention to detail are also important. We spend most of the day on the computer and interacting with staff, clinicians, monitors/sponsors and IRBs. This is a **remote and in-person hybrid position** **(centered in Phoenix, Arizona), working normal business hours Monday - Friday.**

Your pay and benefits (Total Rewards) are important components of your Journey at Banner Health. Banner Health offers a variety of benefit plans to help you and your family. We provide health and financial security options, so you can focus on being the best at what you do and enjoying your life.

Banner Research is at the leading edge in a new era of scientific discovery and innovation. Our basic and clinical research faculty turns ground-breaking research findings into new identification, treatment and prevention methods for diseases such as Alzheimer's, Parkinson's, Cardiovascular disease, Cancer and Orthopedics. We have an international reputation for our work and we provide outstanding access for patients to clinical trials. Our commitment to excellence allow us to make a difference in people's lives every day.

This position, with supervision and under the guidance of senior regulatory staff, provides regulatory support to physicians, clinical investigators and staff involved in the conduct of clinical research projects at the investigative site. May provide daily operational coordination for all regulatory aspects of sponsored, grant-funded and/or investigator-initiated research projects. May handle the submission of regulatory documents and maintain investigative site’s regulatory documents. May ensure coordination of regulatory activities with sponsors, clinical research organizations (CROs), clinical research staff, institutional review boards (IRBs) and other internal and external stakeholders.

CORE FUNCTIONS

2. Assists in maintaining site’s regulatory documents including protocols, investigator brochures, consents, recruiting materials, continuing reviews and safety reports per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines.

3. With some guidance may function as the site’s point-person for the sponsors and CROs, providing requested regulatory documents throughout the life of the study. May participate in site initiation visits for review of site regulatory binders, and during sponsor site monitoring and auditing visits.

5. Performs other administrative duties as required to support senior regulatory staff. Performs all functions according to established policies, procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all customers of Banner Health with an excellent service experience by consistently demonstrating our core behaviors each day.

6. This position assists in providing regulatory support, organization and coordination of research involving all p

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