Quality Control Medical

Donald Daniel DeSousa

**** ******* ***** ********** ***** ● 484-***-**** ● ***********@*****.***

PROFILE/SKILLS

Medical Terminology Multitasking Team Work Self Motivated

Time Management Problem Solving ICU Experience Verification of Data

Management Skills Study Close Out Study Start Up Detail Oriented

Operating Room Experience

EDUCATION

Bachelor of Science, Biology, East Carolina University, Greenville, NC

Dec 2011

Concentration, Molecular Biology

Associates in Arts, Liberal Arts, Montgomery County Community College, Blue Bell, PA

Dec 2007

RELEVANT EXPERIENCE

Clinical Research Coordinator/Clinical Business and Development Associate, CTMG.INC, Greenville, NC

December 2009 - May 2011

• Read and reviewed protocols for trial selection

• Reviewed Investigator Brochures with Primary/Sub Investigators while holding a cross functional review

• Executed informed consent documents for drug and device trials accurately

• Conducted Site Initiation Visits (SIV) with medical staff and PI for site selection

• Adhered to all FDA, ICH-GCP, Central and local IRBs, and state laws

• Conducted prescreening for patient recruitment before consenting patients

• Executed protocol visits and met times lines required

• Trained fellow Coordinators for protocol visits as wells as verify their source documents with their EDC entry’s

• Managed study supplies, study materials, and study product.

• Managed study drug accountability with IVRS and temperature logs on each site

• Executed AE, SAE, Protocol deviations,1572, CV’s for PI/Sub I, DOA, and financial disclosures both electronically and in source documents

• Responsible for specimen collecting, processing, packing, and shipping labs and logging in to IVRS

• Ensured patient stipends accounts were handled accurately and timely

• Completed Source Documents accurately with minimal queries and verified entries in EDC

• Documented the administration of investigational products

• Participated in negotiating contracts between our company and the CRO

• Help create the budgets for the trials procedures, payment structure, and additional fees

• Recruited sub investigators for distal sites and assisted on site selection visits

• Lead coordinator of 4 trials at once, two of which I was in the top 5 sites for patient recruitment in the world

• Assisted in the creation of Source Document templates.

• Certified with multiple EDC platforms.

• Started 3 trials(2 drug 1 device) and closed out 1 (Drug).

Quality Control Technician, Whitford Corporation, Elverson, PA

September 2005 - September 2007

• Directed staff and activities and scheduled staff for the most effective use of manpower, equipment and facility operations

• Supervised and trained technicians, while managing staff of six to ten people

• Worked directly with Research and Development when formulating new products and working on problem lots

• Extensive experience testing raw materials with a variety of tests: pH, viscosity, density, IR, MS, GC, rheology, particle size analysis, color matching, titrations, tension testing

• Confirmed or refuted customer complaints with inventoried lots while working close with Research and Development to remedy any and all issues with problem lots.

• Maintained samples of finished product, shipped products for

• Trained with hazmat materials and trained for clean ups with chemical spills

• Training, directing, and evaluating staff

• Directed staff and activities and scheduled staff for the most effective use of manpower, equipment and facility

• Ensured all GMP processes where maintained.

Project Management, Preferred Contracting Solutions, Philadelphia, PA

January 2002-January-2005

Sold new construction, home rehabilitation, section eight operations

• Experience with problem solving and responsible for interviewing and hiring/firing skilled labor

• Maintained expense sheets, budgeted costs per job, and made time lines for completion of new and existing projects

• Sold jobs and ensured strong customer relations while meeting and exceeding time lines

• Strong verbal skills with extensive work with Excel spread sheets, Power Point, Microsoft Office

• Fielding customer complaints and reassuring our product to the customers to meet their expectation

• Strong individual drive to motivate and ensure moral with staff

• Ensuring customer satisfaction while maintaining a budget and deadline

Certified Nursing Assistant /Unit Secretary, JFK Memorial Hospital, Lantana, FL

Patient Care Assistant, ICU

June 2001 – December 2002

• Took vitals (blood-pressure, pulse, temperature, and respiration) every 15 minutes post operatively on a surgical patient according to protocol (established procedures)

• Measured statistics. Recording intake and output, height, and weigh

• Obtained routine lab samples not requiring laboratory personnel

• Helped patients with ADLs (activities of daily living) such as bathing, combing hair, brushing teeth, shaving, putting on stockings and/or slippers, dressing, ambulation, and toileting

• Helped patients with equipment for their treatment such as anti-embolism stockings, bladder scanner, intermittent pneumatic compression (IPC) devices, transported them to other departments for testing or treatment, Updated and thinned patient charts

• Followed proper protocol in avoiding the spread of germs and spores which transport disease for infection control like staph

• Observed the patient and surroundings, assists the nurse to assess the progress of the patient as well as any needs the patient might have for medical intervention

• On the cardiac code team

Certificates and Training

Antonelli School of Nursing, Pottstown, PA: CNA Certificate 2000

Phlebotomy Certified 2011

CITI Training, -Biotech, GCP, HIPAA 2012

OSHA-blood borne pathogens Certification 2011

CPR Certification 2010

ACRP -Raleigh Chapter 2011

Injections (subcutaneous, intradermal, and intramuscular) trained 2009

ECG Trained 2009

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