Barb Mercier has been in the industry over 25 years, focused on clinical research for medical devices. Key therapeutic areas she has supported to date include cardiovascular class II and III devices, neurology, peripheral vascular and wound care. Barb has excelled in several areas of clinical research, including site start-up activities, clinical trial agreement language and budget negotiations, core lab management and data management for companies such as Boston Scientific, Medtronic and Respicardia, Inc. She has experience on global teams across several geographies including North America, Europe and the Middle East.

CORE COMPETENCIES

• Providing leadership and mentoring to the Clinical Research Associates team
• Assisting sites in Institutional Review Board (IRB) submissions and subject recruitment materials
• Managing site start-up activities including collection of required documents, template creation, review of IRB documentation and informed consents
• Assisting with negotiations of Clinical Trial Agreements and study budgets and the creation of amendments, as needed
• Managing core laboratories: echocardiology, blood, cardiopulmonary exercise and holter laboratories
• Creating and reviewing Standard Operating Procedures (SOPs)
• On-site monitoring visits and on-site qualification visits
• Data Management including site training on database, Clinical Trial Management Systems (CTMS), creating case report forms, data review and database validation
• Managing clinical study payments and maintenance of accruals for subject datasets, subject stipend and IRB fees
• Planning Investigator/Research Coordinator meetings

RECENT PROJECTS

Successfully completed contract and budget negotiations for 25 sites in an investigational device exemption (IDE) trial