Optimize Your Research Compliance and Site Operations
Research compliance is an ongoing commitment. It is the cornerstone of ethical research practices. Our team of experts works with you to navigate the various regulations and guidelines from governing bodies in an evolving and complex regulatory landscape.
Research Compliance and Site Operations
Our team will help you develop, implement, and uphold research compliance and administrative practices in alignment with the federal regulations, state and local laws and industry best practices.
Our team of experts includes deep expertise from R1 institutions and works with you to address:
- Complex regulatory landscapes: We help with navigating various regulations and guidelines from different institutions and governing bodies.
- Resource constraints: We work with research administrations to provide interim, experienced personnel to allow you to scale operations as needed to maintain critical compliance requirements.
- Monitoring: Our team provides post-approval monitoring and auditing services to ensure compliance with regulatory requirements and data safety monitoring plans.
Tailored Offerings
Engage with our team of experts to mitigate risks, protect research integrity, and maintain compliance.
- HRPP assessment and revitalization
- Research compliance assessments and revitalization
- Monitoring/Auditing
- sIRB program evaluation and processes
- SOP development
Engage top-level professionals to fill short- and long-term core team roles both on-site and remotely, bringing necessary skills and experiences to your projects.
- HRPP director
- IRB director/manager
- IRB member
- IRB analyst
- Regulatory coordinators
- Clinical research coordinators (CRC)
- Research nurses
Our Research Compliance Expertise
Julie Moore, J.D., M.S., PA, CIP
Managing Director, Advarra Consulting
Research Compliance and Site Operations
Prior to joining Advarra, Julie spent 10 years in research compliance at academic medical centers. She oversaw single IRB operations She served as the Director of Research Integrity & Compliance at an R1 university, where she served as the Research Integrity Officer (RIO), the Research Privacy Officer, and oversaw the Human Research Protections Program. Julie earned her Juris Doctor degree from Roger Williams University School of Law and is licensed to practice law in Massachusetts and Rhode Island. Prior to attending law school, Julie practiced as a physician assistant, specializing in adult hematology/oncology.
Cheryl Byers, MHA, CIP, CHRC
SVP Advarra Consulting
Faith Bertrand, CIP
Senior Consultant
Lisa Rooney, JD
Managing Expert
John Baumann, PhD, MA, BA
Managing Expert
Cynthia Hahn
Managing Expert
Jonathan Hunter, MA, CIP
Managing Expert
James Riddle, MCSE, CIP, CPIA, CRQM
VP of Research Services & Strategic Consulting
Wendy Tate, PhD, GStat
Director, Advanced Analytics and Research Optimization
Grant Application Support
When developing a grant budget, how do you ensure you’ve included everything your project will need?
Maximize your funding request and avoid resources surprises down the road with Advarra’s support. Download our grant application checklist for an outline of common (and sometimes forgotten) elements you may need to include in your budget.
Need a budget estimate for your grant?
Let Our Experience be Your Advantage
At Advarra Consulting, we are more than industry experts. We are former executives and practitioners. We are professionals with deep experience and a relentless focus on continuous improvement. We understand your challenges and partner to deliver customized solutions to fit your unique needs. We know what it takes to build the infrastructure to establish, administer, and evolve compliant research programs. We stand ready to help you deliver.
Related Resources
Top-Tier University Stays Compliant with Advarra’s HRPP Assessment
A top -tier university worked with Advarra’s Institutional Research Center of Excellence to assess HRPP compliance with federal regulations
Beginner’s Guide to Clinical Trial Billing Compliance
Ensuring proper compliance within clinical trials is confusing, so here are best practices to ensure charges and claims are correctly routed
Developing an Emergency Preparedness Plan for your HRPP
Emergency preparedness plans help institutions plan, prepare for, and respond to emergencies as they arise.
