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Banner is looking for a Senior Research Compliance Analyst. The core scope of the position is monitoring and auditing research study activities for compliance with Banner Health, Banner Research policies, and federal and state regulations. If you have five years' background in clinical studies, hold yourself to high standards, and want to be an expert in the field of research regulations and research compliance, apply today!
Your pay and benefits are important components of your journey at Banner Health. Banner Health offers a variety of benefits 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 Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer's without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. BAI is committed to improving people's lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's research and care.
POSITION SUMMARY This position uses critical thinking and research expertise to audit or monitor research conducted at Banner Health to confirm compliance with applicable federal, state and local regulatory standards, sponsor requirements, and regulatory review committee (IRB, IACUC, IBC, etc.) policies and procedures.
CORE FUNCTIONS 1. Performs audits of research projects conducted with Banner Research. Audits research records, source documentation, and/or billing practices to monitor compliance with applicable regulations. Identifies areas of potential risk through audit processes, as well as assists with presentation of audit findings and design and monitoring of necessary corrective action.
2. Assists in providing monitoring support for all facets of clinical trials and research with a special emphasis on institutional (investigator-initiated) projects. Performs monitoring visits to assure the research data with accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
3. Researches regulatory and billing requirements and develops audit tools and report forms at the direction of the compliance leadership team.
4. Identifies training opportunities based on audits, designs and presents such education to prevent repeated compliance risks at the direction of research regulatory affairs leadership. Provides compliance/documentation education sessions to investigators/scientists and research staff.
5. Assists the organization's Research Compliance Officer/designee and/or regulatory research review committees with the investigation and follow-up on reported issues as directed.
6. Maintains awareness of applicable laws, regulations and practices to maintain research compliance. Reviews related policies and procedures and literature. Communicates applicable coding/compliance issues to the compliance officers and assists in the distribution of training of such changes.
7. Assumes additional responsibilities to assist and support the research regulatory affairs program often dealing with complex and unique situations and problems.
8. Performs job functions on a system-side basis. Internal and external customers include, but are not limited to, executives and managers, compliance committees, physicians and clinical staff. Must maintain professional research certification.
Requires knowledge typically gained with completion of a Bachelor's degree in science, clinical research or other health related field or at least five (5) years of substantial and ongoing professional experience working in a research environment. In addition, an equivalent combination or education and experience may be allowed.
Must possess knowledge and understanding of research regulations and guidelines, as well as HIPAA and patient privacy laws. Requires clinical knowledge, critical and analytical thinking skills to conduct research compliance audits and draft reports. Computer skills in word processing and spreadsheets required. Ability to organize workload, manage multiple projects, and maintain confidentiality of all work information.
Professional designations such as Certified Clinical Research Professional (CCRP(r)), Certified Clinical Research Coordinator (CCRC(r)), Certified Clinical Research Associate (CCRA(r)), or Certified in Healthcare Research Compliance (CHRC(r)) are strongly desired.
Additional related education and/or experience preferred.
What might draw you to Banner Health? A great health care career, of course—and a great place to live, no matter what stage of life you’re in. With facilities across the West, there is a health care career for everyone, from big city living in the Phoenix area to friendly small towns in the mountains and plains. As one of the largest nonprofit health systems in the country, Banner Health offers both the stability that comes with success and the possibility of exploring new areas of the country. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages:
Our expansive system offers you an unmatched variety of clinical settings – from large urban trauma center to small rural hospital, ambulatory to home health.
Our commitment to healthcare innovation means you always have the latest technologies at your fingertips to help you provide the finest care possible.
The size, success and growth of our system provide you with the stability and options to pursue your desired career path.
Competitive compensation and comprehensive benefits offer you options to complement your unique needs.