Research Regulatory Coordinator

Job Functions, Duties, Responsibilities and Position Qualifications:

We're not just a workplace - we're a Great Place to Work certified employer

Proudly certified as a Great Place to Work, we are dedicated to creating a supportive and inclusive environment. At Sonic Healthcare USA, we emphasize teamwork and innovation. Check out our job openings and advance your career with a company that values its team members

The Research Regulatory Coordinator (RRC) will be responsible and accountable to ensure that The Aurora Research Institute complies with all industry specifications, standards, regulations, and laws. The RRC is responsible for conducting reviews and internal audits of all operational practices, creates and enforces regulatory compliance plans, and performs regular and routine regulatory risk management assessments.

Location: Las Vegas, Nevada

Days: Monday - Friday

Hours:  8:00 AM - 5:30 PM

Full-time: Benefit-Eligible

In this role, you will:

• Become familiar with all active study specifications and criteria associated with each and every active ARI Study. Determine if regulatory requirements necessary to conduct each Study have been met and initiate any action or submission if necessary and appropriate.
• If based out of an active ARI Research Site, participate in operational and production processes in order to maintain familiarity with ARI's protocols and procedures as well as contribute to monthly revenue generation. 
• Become familiar with all State and Federal regulations pertaining to the ethical collection, storage and distribution of biospecimens for research as outlined in the Health Insurance Portability and Accountability Act ("HIPAA"); "Common Rule" regulations and the Notice of Proposed Rulemaking ("NPRM") to amend the Common Rule; Food and Drug Administration ("FDA"); and the National Institutes of Health ("NIH") Genomic Data Sharing Policy.     
• Provide initial training and ongoing education to recently hired and existing Clinical Research Coordinators so that they are aware of all pertinent regulations to the extent that they can effectively incorporate them into Standard Operating Good Practices in their daily routine responsibilities.     
• Conduct occasional scheduled and unscheduled internal Audits at all study locations to evaluate compliance and review all on-site regulatory documentation, binders, processes and procedures designed to better prepare for any external or Institutional audits as they may occur. Travel to research sites as necessary to provide higher levels of  on-site guidance and oversight.
• Personally attend and participate in any formal on-site FDA or Institution-initiated Audit procedure.
• Work with the Research Sites and draft and submit and all IRB Study Applications, renewals and amendments for review and approval. 
• Work with Senior ARI Managers to educate and update leaders as to new compliance updates, regulation changes and network regulatory issues.  
• Help to establish and maintain a centralized file share repository of all regulatory/ compliance documentation representing all research sites throughout the ARI network. Capture and archive all IRB, HIPAA, CLIA, CAP and Federal Regulation related correspondence. Use archived documentation as well as site-specific documentation to assist in the establishment and maintenance of Study Site Regulatory Binders to be kept at each participating ARI site.
• Work together with the ARI Management Team to provide monthly ARI Regulatory Compliance Reviews summarizing relevant monthly activity and to highlight areas that require escalation and priority attention.
• Continue to assist local staff in the timely completion and management of Sponsored Clinical Trials as available and as required.
• Complete annual training programs within the required timeframe and regularly attend staff meetings as requested.
• Maintains strictest confidentiality
• Comply with all State, Federal, professional regulations as well as company and departmental rules, polices, and procedural manuals
• Adherence to HIPAA, Safety and OSHA Regulations

All you need is:

• BA/BS/MA/MS science related degree preferred. Previous Clinical Research Coordinator and Research Regulatory experience required
• Previous Clinical Research Coordinator and Research Regulatory experience required.

Must possess experience working with highly detailed clinical research protocols. Knowledge of hospital departmental policies and operations helpful. Experience or knowledge of histology, cytology and pathology strongly desired. Supervisory or management experience desired. 

Company:

Sonic Anatomic Pathology

We'll give you:

• Appreciation for your work
• A feeling of satisfaction that you've helped people
• Opportunity to grow in your profession
• Free lab services for you and your dependents
• Work-life balance, including Paid Time Off and Paid Holidays
• Competitive benefits including medical, dental, and vision insurance
• Help saving for retirement, with a 401(k) plus a company match
• A sense of belonging – we're a community

Scheduled Weekly Hours:

Work Shift:

Job Category:

Company:

Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.