Technical Writer

Linda Wilkerson

**** **** **** ***

Raleigh, NC 27613

(Cell) 919-***-****

******************@*****.***

Profile

Nineteen years of experience working with Contract Research Organizations

(CROs) and Pharmaceutical, expertly gathering and analyzing data for highly

confidential clinical trials.

One year as a Technical Writer. Re-writing computer manuals in laman

terms. Presented and trained staff.

Proficient in defining protocols for clinical studies and handling trial

responsibility throughout the data-management lifecycle.

Advanced skills in EDC systems, well-versed in cGCP and FDA standards and

regulations, and knowledgeable in therapeutic indications.

Experience

Quintiles, Inc. (Site ID Specialist)

December 2006- November 2014

Performed, managed and coordinated activities associated with

identification of sites for projects or programs.

Served as the Site ID Lead for projects and/or programs for the larger or

more difficult trial studies.

Independently managed assigned site identification projects.

Assisted Site ID lead on projects with increased protocol complexity, site

numbers and/or customer SOPs or processes.

Utilized historic site performance metrics, cluster sites, partner sites,

feasibility data, and other data to identify potential sites.

Submitted and reviewed investigators for quality assurance status as

applicable.

Tracked all project activities in Quintiles Database system.

Managed template documents for Confidential Disclosure Agreements (CDAs)

and Site Interest Forms (SIFs).

Distributed, tracked and negotiated the Confidential Disclosure Agreements

(CDAs) with assistance from Management / QLegal as appropriate.

Designed, distributed, tracked and reviewed Site Information Forms (SIFs)

for completeness, site capability and availability.

Provided project progress reports to Internal and External project teams

including department management.

Adhered to project timelines.

Contacted Feasibility, Medical Scientific Services and Clinical Operations

leads to develop plan for identifying potential sites and processes for

assigned projects.

Reviewed and tiered sites for contact based on historical site performance

and other required criteria.

Entered new sites and investigators into the Quintiles Database, reviewing

entries for duplicates.

Transferred applicable data and documentation to Clinical Operations.

Maintained departmental files, including site list and other project

materials as required.

Responded to site questions about assigned studies in a timely manner.

PAREXEL, Inc (Clinical Support Specialist) June

1998-December 2006

Managed study budgets for the therapeutic group

Liaised with the clinical team and investigators in order to process

quarterly payments

Processed, tracked and reported invoices and investigator payments toward

study budget

Contributed to the standardization and dissemination of best practices

across the organization

Created, generated and analyzed monthly reporting for accuracy

Reviewed regulatory documents and negotiated contracts and budgets for site

initiation

Contacted sites as required to resolve issues for regulatory approval

Prepared and submitted submissions for Independent Ethics Committee (IEC)

or Institutional Review Boards (IRB)

Submitted documents to appropriate internal departments in order to obtain

regulatory approval for initial drug shipment

Shipped subject recruitment materials, reorder of drug shipments, budget

amendments and protocol amendments to site as requested

Managed data tracking entries into designated clinical tracking systems in

accordance with project requirements

Processed, tracked and reported invoices and investigator payments toward

study budget

Liaised between sites, IRB/IEC, monitors, study management teams and CRO

Audited and reported on internal investigator files and or CRO files

Wrote the process for financial payments for US and International

countries. Presented and train staff.

Miscellaneous tasks as needed

Wake County Human Services (Technical Writer)

January 1998- May 1998

Manpower Technical

Worked with Lotus Notes Developer to develop program for the Wake County

Head Start Program for children ages 3-5.

Worked with Lotus Notes Developer to develop the program for Wake County

Smart Start for children ages 4-5.

Wrote the user manual and presented this information to the State and

Federal Government for approval. Wake County still has this program in

place.

Glaxo Welcome, Zebulon, NC (Assistant to Technical Writers)

August 1997- December 1997

Manpower Technical

Assisted Technical Writers and Project Managers with miscellaneous tasks as

needed.

Education

Pitt Community College, Greenville NC - Business Computer Programming - AA

Degree 1992 - 1995

Palm Beach Junior College, Lake Worth, FL - Elementary Education - AA

Degree 1973 - 1976

Anita Priest School of Design - Ft. Lauderdale, FL - Certified in Interior

Design 1977 (2 Months )

Bauder Fashion College, Atlanta, GA - Certified in Merchandising and

Modeling - 1968 - 1969

Skills

EDC Systems (Intrax, Informatics, Clinical Informatics, CTMS, Infosario);

MS Office (Word, Excel, Project, PowerPoint, Outlook)

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