Professional Documents
Culture Documents
Baker
2748 South Telluride Ct
720-870-0349 home
303-887-1657 cell
janellbaker@msn.com
Work History
Colorado Orthopedic Consultants
1411 S. Potomac St. Aurora, CO 80012
February 28, 2008 – present
QA Data Manager – Clinical Research Department
• Performs QA internal audits on all subject charts, across all protocols, to ensure that
GCP and protocol guidelines are being adhered to.
• Extrapolates data, completes case report forms, and ensures timely data submission in
accordance with SOP.
• Utilizes multiple electronic data systems to access research forms and keeps current
all applicable patient reporting and tracking functions including but not limited to
Medidata Rave and Oracle based systems.
• Actively prepares for and participates in monitoring and auditing activities.
• Assists in ensuring that all queries are resolved in a timely manner in accordance with
SOP and sponsor requirements.
• Responsible for processing, filing and maintaining protocol regulatory documents.
• Oversees and maintains the on-call schedule for the study coordinators. Oversees
scheduling study coordinators work schedules when required by particular protocols.
• Performs study visits which may include phlebotomy and processing samples, ECGs,
spirometry, and vital signs.
• Provides technical support for network, desktop computers and peripherals.
Education/Certifications
Janell K. Baker
2748 South Telluride Ct
720-870-0349 home
303-887-1657 cell
janellbaker@msn.com
Continuing Education
“GCP Training Seminar”. Certificate of Completion. July 30, 2008.
“Protecting Human Research Participants”. Certificate of Completion. June 4, 2008.
Organizations/Affiliations
Society of Clinical Research Associates (SOCRA) 2009 - current
Computer Skills
• Highly skilled and effective computer technician with professional certificates in C++
Programming, Client Java Programming, Software Engineering Methods, and Object
Oriented Methods
• Visual C++ 6.0, JBuilder 9.0, Forte for Java CE, Microsoft Project 2000, Visio 2002,
• Microsoft Windows Client/Server applications 98/2000/XP/ SBS 2003,
• Timekeeper Central, Fifteen years of functional experience using Meditech Software,
BillingLogic/Chartlogic EMR, LSS EMR