Heather Robertson
San Jose, CA 95123
*******************@*****.***
OBJECTIVE:
A project support position where my strengths in organization, planning,
and customer relations will contribute to meeting project objectives and
company goals
SUMMARY:
Highly self-driven and meticulous professional with 7+ years of experience
working with small and large pharmaceutical companies and CROs including 4+
years direct experience in Project Management. Excellent interpersonal
skills with proven ability to work with a variety of personality styles and
cultures in a friendly, professional, and diplomatic manner.
PROFESSIONAL EXPERIENCE:
Omnicare Clinical Research
Senior Project Coordinator 2010-2011
1. Attended on-site and off-site project team and client meetings as
required
. Assisted project team by coordinating/updating team on weekly progress of
regulatory document collection during study start-up and as
specified in the communication plan
2. Coordinated and set up project meetings including internal, CRA, client
meetings and
training presentations
3. Prepared and distributed quality minutes within a specified timeframe
4. Performed project/patient/CRA enrollment logs and regulatory tracking as
required
5. Provided administrative support required to do mass mailings to
investigative sites
6. Managed project correspondence, copying and distribution of documents
7. Maintained and updated study specific templates
8. Site document control and recording- including tracking of site
documents and Trial Master File maintenance and QC
9. Assisted the project team to address findings arising from the Trial
Master File QC and track any actions for resolution
10. Supported the project team in the final QC of the Trial Master File
prior to archiving
Clinimetrics Research Associates, Inc.
2007-2010
Project Assistant
. Organized and retained site regulatory documentation files
. Prepared and maintained the project Trial Master File for archiving
. Assisted with the collection, review, and tracking of regulatory
documents and IEC/IRB materials as well as preparation of submissions
. Implemented patient tracking systems, entered patient enrollment
information, and compiled enrollment reports
. Attended project and client meetings and prepared minutes, as needed
. Communicated with clients as necessary on any aspect of the projects
. Disseminated study information to project team members
. Processed and issued site grant payments
. Performed additional administrative support duties, as requested
Clinimetrics Research Associates, Inc.
2005- 2007
Quality Assurance Associate
. Assisted with the preparation for Investigator site audits conducted by
the QA/Compliance Department
. Provided assistance with the preparation for client and FDA audits of
Clinimetrics
. Prepared and performed QA audits of clinical data
. Assisted QA/Compliance Department with query resolutions
. Provided support with the maintenance, distribution, and tracking of
Clinimetrics SOPs
. Assisted with the maintenance of personnel training records
. Assisted with and maintained sensitive documents and records
(electronic and hard copy)
Clinimetrics Research Associates, Inc. 2003-2005
Central Files Associate
. Processed monitoring visit reports submitted to Central Files for
multiple
pharmaceutical clinical trials
. Scanned visit reports utilizing KwikTag document imaging software for
document control and retention
. Filed and maintained reports, in accordance to departmental guidelines
. Supported QA/Compliance Department as needed
Crest Financial Services/Vishay Siliconix (through Manpower)
2002
Receptionist
. Filed essential documents; greeted clients; answered phones and routed
important
papers to other offices
Manpower Staffing Services 2001
Customer Account Specialist
11. Processed weekly payroll for temporary employees and subcontractors
12. Assisted the billing/collections department
13. Managed invoicing to customers
14. Accurately sorted and filed timecards
Service Merchandise 2000-2001
Customer Service Representative/Audit Administrator
15. Assisted customers in the jewelry department with superior customer
service
16. Balanced registers and processed necessary sales and refund receipts
17. Verified audit reports and sales
EDUCATION:
Certificate of Completion for Microsoft Excel, Rockhurst University
Continuing Education, San Jose, CA, 2008
"How to Make Outlook Work Harder for You," Rockhurst Web Conference,
San Jose, CA, 2007
Medical Assistant Terminology Certificate, Central County Occupational
Center, San Jose, CA, 2005
Certificate of Completion of Computer Applications, Central County
Occupational Center, San Jose, CA, 2004
High School Diploma, Santa Teresa High School, San Jose, California
Computer Skills:
Microsoft Word, PowerPoint, Excel, Outlook, FileMaker Pro, KwikTag
Document Imaging Software