Project Manager

D E R R I C K D. C A R T E R

***** ******** ** . ********, ** 20165 . 404-***-****.

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

Summary of Qualifications

. Policy Design and Administration

. Protocol Development

. Database Development

. Project Management

. Trial Monitoring experience

. Training & Development

. Knowledge of FDA regulations and guidelines, including 21 CFR Part 11

. Regulatory Affairs/Submissions

. Contract negotiations

. Clinical and Administrative Leadership

. Site Initiation and close out visits

. GLP and GCP experience

. Technical Lab export

. Quality Assurance

. Vendor management

.

Professional Experience

Animal Clinical Investigation Washington, DC

Dec 10-Present

Project Manager

. Serve as primary liaison between investigators, site coordinators,

medical director and sponsor project manager.

. Manage day-to-day business and conduct of clinical trials, including

maintaining the integrity of the protocol, the regulatory process, and

the resulting data; maintaining proper documentation and monitoring

the progress of the study; maintaining key relationships; managing sub-

contracts including academic sites and third-party vendors

(laboratories, couriers, etc.) as requested by the Sponsor.

. Assist the VP of Clinical Affairs, other Project Manager(s), Site

Coordinators, and Monitors in preparation for and training of all

clinical trial site staff.

. Development and/or implementation of a management system for the trial

including written policies and procedures (Monitoring Plan, Data

Management Plan), and accompanying forms

. Train site staff and perform other personnel functions as required for

study protocols and or procedures

. Assist with preparing budget(s) as requested

. Operate under GCP practices

. Serve as or assist as Clinical Research Associate for assigned project

Highlights & Accomplishments

. Collected a wide range of tumor samples for analysis from specific

cancer patients post operative and or during surgery.

Covance Vienna, VA/ Chandler, AZ

Mar 08-Aug 10 Study Technician II

. Assume the role as Head Technician or back-up technician on multiple

studies ranging from one month to one year from various pharmaceutical

and other drug discovery companies.

. Interpret protocols, recognize details, and deviations from expected

results while conducting it under SOP and governmental regulations.

. Perform basic restraint and dosing procedures on primates, canines,

rats, and or mice that include intramuscular, intravenous,

intradermal, subcutaneous and various phlebotomy techniques.

. Maintain well documented laboratory records to show proof and accurate

results to insure data information that correlates in GLP standards.

. Effectively monitor surgeries and notate vital signs to ensure that

the procedure is under control.

. Train or assist with the training of new employees to familiarize them

with company policies and standard operating procedures.

Highlights & Accomplishments

. Aided in the successful launch of a new facility in Chandler,

Arizona

. Helped to establish a standard process of data collection,

validating studies and its equipment, to facilities and its setup.

. Completed a "Train the Trainer" course that certifies employees to

teach and train others.

. Held training sessions required for all employees that include

classes pertaining to General Orientation, Internal and External

Diversity, and Signature Client Service.

. Liaison between 3 different departments in order to establish a free

flowing and open communication line.

. Recognized as one of the top "Peer Facilitator" in the West and

nominated for the Global Award in the Learning and Development

Department

Metametrix Clinical Laboratory Duluth, Ga

June 07-Feb 08

Special Chemistry Technician

. In a clinical laboratory, handled biohazardous body fluids such as

serum, plasma, and whole blood following universal handling

precautions.

. Primary operator and troubleshooter of an assigned specialty

instrument such as GCMS and HPLC to analyze samples such as stools,

amino acids, red blood cells and or plasma.

. Prepares samples for quantitative analysis following documented

protocol for various specialty nutritional assays.

. Prepares various solutions such as calibrators, buffers, and reagents

and make in house control materials as needed.

Highlights & Accomplishments

. Became proficient on GCMS and HPLC to run a variety of multiple

samples for different tests

. Train new employees and Auditors on GCMS and HPLC processes and

procedures through SOPs and protocol interpretation

Georgia Pacific Decatur, Ga

Sept 06-May 07 Chemical Technologist (Contract)

. In a laboratory setting, worked with volatile chemicals to include

Phenol, Formaldehyde, HCL, and Sulfuric Acid to make resins and resin

derivatives.

. Utilized high temperature reactors, pH meters, bubble tube viscometer,

Instron, and other instrumentation on daily basis

. Maintained and recorded data in an up-to-date lab notebook.

. Researched and developed new ideas to meet customers' demands and

improve product performance

. Utilized PMI to perform a multiple-step synthesis of organic resins

Highlights & Accomplishments

. Ran a self planned validation study to maximize results between

two hot melt adhesives.

EDUCATION AND AFFILIATIONS

Georgia State University, Atlanta, Ga

August 2006

Bachelor of Science, Biology with a minor in Chemistry

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