Featured image for post: Shawna Cote, M.S., CCRA, CCRC

Shawna Cote, M.S., CCRA, CCRC

Chief Compliance Officer and Director of Quality

Ms. Cote was elevated to her current position in January 2020, bringing with her over 10 years’ experience as a Contract Research Monitor and a 14-year history of site management.

Ms. Cote ensures Apex sites adhere to the highest standards of ethics, integrity, and responsibility in their research programs, overseeing legal and regulatory affairs, quality assurance, strategic partnerships, and vendor relationships. She monitors research projects to ensure they comply with the relevant legislation, reviews laws to identify changes that might affect research projects, and develops effective institutional compliance policies to support staff conducting research.

Ms. Cote is leading the implementation of a comprehensive compliance training program and a harmonization of standard operating procedures and best practices from lessons learned from decades of Apex sites conducting trials. Committed to safety during the COVID-19 pandemic, Ms. Cote ensures Apex sites are meeting and exceeding safety standards and regulations, including the recommendations provided in the FDA’s Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.

Work History

Ms. Cote briefly worked for CNS as Quality Assurance Coordinator before accepting the role of Director of Operations at Pacific Research Partners upon its establishment in 2010. Earlier on she was Senior Clinical Research Associate at Quintiles in San Diego from 2004 to 2010.

Ms. Cote worked for Diablo Clinical Research in Walnut Creek, CA from 1992 to 2003, starting as a Clinical Research Assistant before becoming a Clinical Research Coordinator, Lab Manager, and Quality Assurance Manager. She has also worked as a Contract Research Monitor and a Clinical Research Consultant for various organizations.


Ms. Cote obtained her M.S. in Clinical Trial Administration from Walden University and her B.S. in Health Science from California State University, Hayward (now California State University, East Bay). She has earned CCRC and CCRA certifications from the Association of Clinical Research Professionals.