Donnetta Moore Hardy

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

Savannah, GA 31406

269-***-**** (cell)

abnpg0@r.postjobfree.com

CAREER OBJECTIVE:

To advance my career as a Clinical Research Associate by becoming part of a dynamic

and growing organization in this discipline, using the capabilities, determination, and skills

demonstrated in my education and work experience

SELF DEFINITION:

I love learning! I enjoy a team environment that stresses mutual respect and cooperative

achievement. I thrive on variety, challenging tasks, and working hard in an environment

that values open dialogue and individual initiative.

KNOWLEDGE AND SKILLS:

• Excellent clinical trials monitoring skills including but not limited to conduction of

qualification, initiation, monitoring and close out visits; working knowledge of clinical

research practices and familiarity with clinical laboratories’ environment, practices and

requirements

• Excellent team player with team building skills

• Demonstrated ability to mentor and train other monitors in a positive and effective

manner

• Demonstrated ability to perform detail oriented work with a high degree of accuracy

• Demonstrated ability to evaluate medical research data- specialty therapeutic areas

being Oncology, and Dermatology, Phase I and II trials, and proficient knowledge of

medical terminology

• Effective organizational skills and strong attention to detail

• Effective oral and written communication skills

• Effective work planning and organizational skills including budgeting for material

requirements

• GMP,GCP/ICH,GLP

• Effective interpersonal skills

• Effective negotiation skills

• Basic computer skills to include EDC and ability to learn and become proficient with

appropriate software

EDUCATION:

CRA/CRC Professional Development Program; Clinical Research Training Institute;

June 2008

Bachelor of Arts Degree; Chemistry; Olivet College; Olivet, MI; May 2003

Master of Science Degree; Environmental Management; Samford University;

Birmingham, AL; May 1999

Bachelor of Science Degree; Biology; Grambling State University; Grambling, LA;

December 1994

WORK EXPERIENCE:

Analyst II; Testamerica Inc. Savannah, GA; January 2007-Present

• Perform preparation and analysis of liquid and soil samples for cold vapor mercury

analysis.

• Maintain accurate testing records, logbooks and reports.

• Comply with all GMP requirements as controlled by laboratory Quality Assurance.

• Perform daily equipment calibration and maintenance.

Analytical Chemist; Pharmacia/Pfizer; Kalamazoo, MI; November 2001-November

2006.

• Perform physical and chemical testing on outside purchased materials (actives and

excipients), as well as some active ingredients manufactured at Pharmacia, in support

of KPO manufacturing.

• Maintain accurate testing records, logbooks and reports.

• Perform periodic equipment calibration as needed.

• Comply with all GMP requirements as they apply to the pharmaceutical Quality

Control laboratory.

• Perform testing on water for injection and purified water samples

• Working knowledge and familiarity with USP and EP compendia guides

• Performed computer and equipment validation of new equipment.

• Performed method and compendia qualification.

• Performed procedure revisions and authored new sop’s and user guides.

• Executed IQ,OQ, and PQ as part of validation processes, including authorship of

documents and reports

Clinical Research Associate (Independent Contractor); Health-Works1 LLC;

Kalamazoo MI; October 2005-Present.

• Plan, schedule, and carry out day-to-day clinical activities and procedures, ensuring

efficient work-flow and adequate care and treatment of research subjects.

• Coordinate the care and treatment of patient research subjects; coordinate services with

other internal departments and agencies.

• Ensure appropriate adverse event review, reporting, audits, and other related

procedures.

• Participate in education of clinical staff, investigational drug service, and other center

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Donnetta Moore Hardy 269-***-**** abnpg0@r.postjobfree.com

staff regarding the studies and related procedures.

• Coordinate clinical services and procedures to patient participants as required by

specific needs of the protocol.

• Coordination of the internal and external IRB approval process for assigned trials.

• Develop and implement clinical trial protocol related forms, questionnaires and

documentation

• Achieved an “outstanding” performance review in data collection, teamwork, quality, and

written verbal communication skills.

Water Pollution Control Compliance; Jefferson County; Barton Lab; Birmingham, AL;

April 1996-June 2001.

• Determine composition of wastewater using GC/MS, Atomic Absorption, Mercury

Analyzer, TRACCS, Flow III and Wet Chemistry analysis

• Obtain relevant information and identify key issues in chemical analysis of wastewater

• Relate, compile and analyze data to track and monitor trends of water samples

• Develop and maintain an effective reporting system to wastewater treatment plants in

the Jefferson County area, involving government regulations such as RCRA, Cercla,

CWA, and OSHA.

• Submit reports and recommendations on all work on systems

• Maintain files, charts and reports on work in progress and inspections

• Investigate and report on problem areas and special projects

• Organize and maintain required documentation of water samples

• Certified in statistically valid detection limits and fundamental/troubleshooting of

GC/MS

• Evaluated concentrations of water samples

• Interpret the statistical data of water sample analysis

• As team leader upon encountering incorrect data, I troubleshoot instrumentation and

report to my immediate supervisor

• Implemented training course for new staff which directly relates to the successful

operation of analyzing water samples

• Developed process and methods to statistically analyze and interpret data from water

sample analysis to solve problems

Commodity Grader; U.S. Department of Agriculture; Birmingham, AL; 1995-December

2001.

• Classified cotton in accordance with federal quality standards

• Served as a technical liaison between federal, state and municipal governments

• Reviewed cotton samples according to regulations set by the USDA

• Certified cotton commodity grader

PROFESSIONAL AFFILIATIONS:

• American Chemical Society

• The Water Environment Federation

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Donnetta Moore Hardy 269-***-**** abnpg0@r.postjobfree.com

• Grambling State University Alumni Association

REFERENCES:

Available upon request

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Donnetta Moore Hardy 269-***-**** abnpg0@r.postjobfree.com

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