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.
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.
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.
Researches regulatory and billing requirements and develops audit tools and report forms at the direction of the compliance leadership team.
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.
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.
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.
Assumes additional responsibilities to assist and support the research regulatory affairs program often dealing with complex and unique situations and problems.
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), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or Certified in Healthcare Research Compliance (CHRC) are strongly desired.
Additional related education and/or experience preferred.
You want to change the health care industry – one life at a time. You belong here. You’re excited to be part of the dramatic changes happening in the health care field. In fact, you thrive on change. But you also understand that excellent, compassionate patient care is the true measure of the success of these changes. You belong at Banner Health. Our award-winning, comprehensive health system includes 23 hospitals in seven western states, primary care health centers, research centers, labs, a network of physician practices and much more. Throughout our system, skilled, compassionate professionals use the latest technology to change the way care is provided. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages: •Our vision for changing the future of health care gives you the opportunity to leverage your abilities to achieve something historic. •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 system also includes hospitals specializing in cancer, heart health and pediatrics. •Our many loc...ations also translate into a broad selection of exciting and rewarding lifestyle options – from the big city to the wide-open spaces. •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. •Our competitive compensation and comprehensive benefits offer you options to complement your unique needs.