Sioux Falls, SD, 57117, USA
1 day ago
Research Compliance & Privacy Consultant
**Location:** Avera Health Broadband Lane **Worker Type:** Regular **Work Shift:** Day Shift (United States of America) **Pay Range:** _The pay range for this position is listed below. Actual pay rate dependent upon experience._ $58,240.00 - $87,360.00 **Position Highlights** **You Belong at Avera** **Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.** **A Brief Overview** The Research Compliance & Privacy Consultant has the responsibility for promoting and assuring the ethical conduct of research at Avera. This position is accountable to review and manage research related compliance matters including allegations of research noncompliance, conflicts of interest related to research, and allegations of research misconduct. This position conducts routine and for-cause compliance audits to ensure accuracy, privacy and compliance with all protocols and relevant policies and regulations. This position will also conduct research billing audits. Prepares audit reports to present to research investigators, administration, and compliance team. Conducts focused education and training based on findings from risk assessments and audits, regulatory changes and enforcement activities, and new policies and procedures. Additionally, this position will support privacy-related programs, such as privacy walk throughs, privacy auditing and reporting. **What you will do** + Requires a detailed knowledge of regulations regarding the use of human subjects in clinical trials. Researches and remains abreast on national research compliance trends and activities and the impact on the system. Serve as a Privacy Liaison expert to the Institutional Review Board (IRB). + Conduct routine and for-cause audits of research protocols to ensure their accuracy and compliance with federal and state laws and regulations. These audits involve three parts, including the review of documentation for research subject charts, a pharmacy audit, and a regulatory audit. + Facilitate research patient billing audits, analyze the data, and utilizes metrics to measure institutional clinical research billing compliance. Assists in liaison with billing offices on development and streamlining of clinical research billing processes. + Analyze existing and pilot institutional clinical research billing compliance initiatives. + Encourage research integrity by overseeing all aspects, (inquiries, allegations or investigations) of research misconduct. + Develops, implements, and conduct training programs for research principal investigators, researchers, staff, and students in research compliance. + Support establishment’s privacy-related programs, such as privacy walk through, privacy auditing and reporting. + Respond to concerns from patients, employees, and Office of Civil Rights. + Consult with and advise operating units and managers affected by regulatory requirements. Examines policies, procedures, and practice to ensure compliance with laws, regulations and Good Clinical Practice (GCP) standards. + Support the overall success of Research and Compliance by performing other duties as assigned by leadership. **Essential Qualifications** The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. **Required Education, License/Certification, or Work Experience:** + Bachelor's in Health Care, Business Administration, Political Science or similar + 4-6 years clinical research environment required or minimum four years of combined experience in clinical research or compliance environment. **Preferred Education, License/Certification, or Work Experience:** + 1-3 years Clinical trials auditing/monitoring experience such as internal quality assurance. **Expectations and Standards** + Commitment to the daily application of Avera’s mission, vision, core values, and social principles to serve patients, their families, and our community. + Promote Avera’s values of compassion, hospitality, and stewardship. + Uphold Avera’s standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. + Maintain confidentiality. + Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. + Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable. **Benefits You Need & Then Some** Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. + PTO front-loaded for eligible hires + Free health insurance options, for full-time single coverage on Avera High Deductible Health Plan + Up to 5% employer matching contribution for retirement + Career development guided by hands-on training and mentorship _Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-605-504-4444 or send an email to_ _talent@avera.org_ _._ At Avera, the way you are treated as an employee translates into the compassionate care you deliver to patients and team members. Because we consider health care a ministry, you can live out your faith, uphold the dignity and respect of all persons while not compromising high-quality services. Join us in making a positive impact on moving health forward. The policy of Avera to provide opportunities for all qualified employees or applicants without regard to disability and to provide reasonable accommodations for all employees or applicants who may be disabled. Avera is committed to ensuring compliance in accordance with the Americans with Disability Act. For assistance, please contact HR Now at 605-504-4444. Additional Notices: For TTY, dial 711 Avera is an Equal Opportunity/Affirmative Action Employer: Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity.
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