Accomplished Scientist with expertise in Quality Assurance and Clinical Study Coordination

eager to contribute extensive talents toward supporting a progressive organization in optimizing bottom-line performance.

 

 

         Advanced knowledge of drug development process encompassing FDA regulations, ICH guidelines and HIPAA specific to clinical studies.

         Well-versed in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and lab safety rules and regulations including hazardous materials management, OSHA criteria and chemical hygiene policies.

         Proficiency in designing research experiments, administering quality control to ensure accuracy of data, and maintaining lab instruments and equipment.

         Reliably adhere to company/client Standard Operating Procedures (SOPs).

         Well-developed analytical, troubleshooting, documentation, and organizational skills.

         Able to conduct broad-scope laboratory procedures, use state-of-the-art measurement devices, define analytical standards, evaluate test results, and generate reports.

         Strong multi-tasking abilities; gracefully balance competing priorities.

 

 

Bostwick Laboratories, Richmond, VA, 2007 to 2010

Project Coordinator

• Spearheaded multi-site oncology clinical trials by diligently enforcing compliance with regulatory, corporate and quality requirements.
• Applied sharp organizational skills toward collecting documentation such as regulatory and IRB submission forms, coordinating site training and monitoring, scheduling teleconferences, and assembling procedural manuals for sites. 
• Prepared SOPs and comprehensive reports for clinical trial sponsor and sites.
• Seamlessly closed each study upon trial completion and produced final reports.

 

Lancaster Laboratories, Richmond, VA, 2005 to 2007

Biologist          (2006 to 2007)

         Proficiently conducted molecular biology experiments to support tobacco research, exhibiting strong expertise in PCR, DNA sequencing, mini-preps of plasmids, enzyme digestions, and ligations to vectors. 

         Performed bacterial transformations, tobacco transformations, and electroporation in agro bacterium. 

         Investigated plant tissue and callus tissue culture.

 

Chemist           (2005 to 2006)

• Collected smoke samples using smoke machines, analyzed samples using GC/MS technology and interpreted data for volatile organic chemicals in direct support of tobacco research.

 

Continued

 

 

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Professional Experience continued

 

PPD Development, Richmond, VA, 2000 to 2007  

Associate Scientist       (2001 to 2007)

• Used GC and HPLC instrumentation to analyze biological matrix samples and assess levels of targeted pharmaceutical compound.
• Carefully prepared various solutions, reagents, and extraction solvents, maintained laboratory instrumentation, and evaluated study findings.

 

Scientist           (2004 to 2005)

• Quickly advanced from role as Assistant Scientist (2000 to 2001) and tasked with analyzing biological matrix samples to determine levels of targeted pharmaceutical compound.
• Demonstrated proficiency in using GC, HPLC and LCMS instrumentation and automated equipment such as Tomtec and Tecan. 

         Meticulously prepared various solutions, reagents, and extraction solvents. 

         Scrutinized and summarized project data upon completion of run. 

 

U.S. Army Reserves, 1989 to 2007

Environmental Science Officer

         Supervised four physician assistants and fifteen metal workers in demobilization of physical exam section in support of Enduring Freedom, 2003 to 2004.

         Provided crucial clinical and technical leadership to lab personnel.

• Conducted health inspections on various Army facilities, homes and child care centers.

 

Laboratory Specialist

• Employed excellent clinical and analytical skills to perform procedures such as centrifuging blood, preparing HIV samples for shipment, syphilis testing and phlebotomy.
• In support of Operation Desert Storm, prepared samples for tuberculosis testing, tuberculosis slides by fluorescent staining, and fungal cultures.
• Drew blood and ran complete blood counts using Cell Dyn 3000 and Cell Dyn 3500.
• Interpreted various slides, performed ESR and sickle cell test, and collected samples on soldiers for DNA analysis and recording.

 

Hayes E. Willis Health Center, Medical College of Virginia Hospital, Richmond, VA, 1994 to 2000

Laboratory Specialist

• Exercised precision in performing wide range of lab procedures including centrifuging blood, dip stick analysis, pregnancy testing, rapid strep test, finger stick glucose, and complete blood counts using the Coulter MD16. 

                  

Prior experience includes role as Research Assistant for Division of Neurosurgery, Medical College of Virginia, 1992 to 1993.

 

 

B.S. Biology, Virginia Commonwealth University, Richmond, VA, 1992

 

Professional Development:

 

Certificate in Monitoring Clinical Studies, Clinical Research Training Online, 2007

Certified Laboratory Specialist, Academy of Health Sciences, Fort Sam Houston, TX

CCRP (Certified Clinical Research Professional), SoCRA (Society of Clinical Research Associates)

 

                

 

 

 

 

 

Date

 

 

 

Hiring Agent Name

Title

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I am currently seeking a challenging career opportunity as a <insert job title/position> and am submitting my resume for your review.  In advance, thank you for your time and consideration.

 

In addition to excellent academic and professional credentials, I bring to you solid experience in scientific laboratory operations, outstanding expertise in quality control and assurance, and an exemplary blend of talents in clinical study coordination and site monitoring, GMP and GLP compliance, laboratory equipment and instrument calibration, and report preparation. To complement these qualifications, I offer polished analytical, technical, and communication skills.   

   

As a proactive contributor to your organization, you will find me to be a self-motivated professional committed to supporting you in achieving your objectives through integrity and dedication. I am confident that I could be a valuable asset to your company, and look forward to interviewing with you in the near future.

 

Sincerely,

 

 

 

Yyyyyy x. yyyyyy