Download Rosalind Simon - Colorado BioScience Association

Lyn Simon
10152 Gaylord Street
Thornton CO 80229
303-434-4150
[email protected]
Experience
2013 – January 2017
Nivalis Therapeutic
Clinical Project Coordinator
 Key team member to facilitate clinical study start-up, recruitment/treatment, and close
out activities
 Facilitated the preparation, handling and tracking of IRB submissions
 Lead the effort to review and track essential documents for the trial master file such as
informed consent documents, IRB approvals, financial disclosure forms and other trial
related forms
 Lead the organization of key meetings (study, investigator, DSMB etc.,)
 Help design tools and manage and track inventory of study conduct tools, drug and nondrug clinical supplies
 Take meeting minutes as appropriate, including higher profile meetings (e.g. KOL,
DSMB, Investigator Meetings)
 Contributed to content of Investigator meeting
 Supports SOP revisions relevant to CPC function
 Leads development and dissemination of best practice across area with minimal oversight
 Assisted with the implementation of a electronic trail master file
2007 – August 2013
Array BioPharma Inc
Clinical Trial Associate
 Assisted with clinical study start up through close out for Phase I, II & III studies in both
asthma & oncology
 Assisted in preparation and submissions of essential documents for local and central IRBs
 Reviewed & tracked essential documents for the trial master file; General Study, Site level &
Compound level
 Maintained the integrity of the clinical trial master files through a quarterly reconciliation
process
 Managed & tracked inventory of conduct tools, drug and non-drug clinical supplies
 Assisted with organization of key meetings, meeting minutes, agenda
 Updated and maintained study and site information in key clinical systems
 Created and tracked Confidentially Agreements, for legal department, through finalization
 Member of two standardization committees where the goal was to streamline the
responsibilities of the CTAs.
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Clinical Department Administrative Assistant
 Assisted and oversee resources such as meeting rooms, equipment, catering
 Event planning for on & off site meetings
 Assisted with creating and submitting Expense Reports
 Coordination of department meetings, agenda
 Assisted with travel arrangements
 Assembled binders for various department trials
 Assisted with the clinical study start-up and close out activities
 Compiled study start up materials
 Assisted with the Trial Master File tracking spreadsheet
1997 - 2007
The Midland Group
Executive Assistant to Director of Operations
• Compiling and Analyzing data for local area hospitals
• Statistical & Financial reports for Department Heads of hospitals
• Created complex queries from corporate database to produce custom reports for customers
• Created & Implemented Administrative Staff Training Manual
• Training of all clerical positions throughout the company
• Scheduling appointments, Coordinate meetings and Organizing office functions
• Document preparation management of all incoming/outgoing correspondences
• Database Management
Education
1995 - 1997
Denver Business College
Associate of Applied Science
• Legal Administrative Management
• Graduated with Honors
• National Dean’s List
Computer Skills
• Type 70 wpm
• MS Office
• Excel
• MS Publisher
• Extensive Internet Knowledge
• MS Outlook
• Adobe Acrobat
• iMedidata/RAVE
• PowerPoint
• VeeVa Vault eTMF
References available upon request
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