Kelly Soprych is a Clinical Research Associate who supports pharmaceutical and medical device developers (in tandem with CROs, when applicable) with clinical trial management. She helps ensure trials are conducted in accordance with Sponsor SOPs, established regulatory guidelines, and GCP and ISO standards. Ms. Soprych visits study sites (in person or virtually) to perform site qualification, initiation, monitoring, and close-out visits, verifying all aspects of data collection, subject accountability, investigational product accountability, and protocol compliance. She also supports study Sponsors and contracted CROs with case report form design, data validation plans, and event coding/classification.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
