Project Manager Customer Service

BRAD ROBINSON, M.S., M.T. (AMT)

** ********* **** ****** *******, Georgia 30127 404-***-**** ************@*******.***

SUMMARY

Accomplished Medical Technologist/ Clinical Project Manager with twenty years of expertise in laboratory testing and clinical project management. Known as a detail-oriented top performer with proven success in all phases of clinical trials from laboratory to project management. Key role in the successful launch and project monitoring of many complex projects, global clinical trials, pharmaceutical studies and six sigma projects. Strengths include:

Medical Technology Specialty in Laboratory Procedures and Operations

Transfusion Services/Blood Bank

Lean/Process Improvement Customer Service

Six Sigma Project Management (DMAIC)

Project Management

Data Analysis Quality Management and Compliance

Change Control

THERAPEUTIC EXPERIENCE

Transfusion Service, Virology, Organ Transplantation Rheumatoid Arthritis, Crohn’s Disease, Oncology, Immunology, Diabetes, Heart disease, Depression, Obesity, Women/Men studies, Infectious diseases, Anxiety, HIV, Hypertension, and Dementia.

PROFESIONAL EXPERIENCE

ATLANTA MEDICAL CENTER, Atlanta GA 2012 - Present

Blood Bank - Supervisor

Leader of a fast paced, highly regulated level 1-trauma center which incorporates all blood bank techniques and products . Strengths include:

• Supervision of nine Medical Technologists.

• Cap inspection with no deficiencies (August 2012).

• Created a policy that will save hospital ~$24,000 per year in new component policies when approved by FDA.

• Key member in decision to save money for hospital by bringing in new instrumentation.

• Validation of our new Immucor ECHO.

• Lookback investigations on donor recalls.

• Blood Utilization Review.

• Develop SOPs of new policies and procedures.

• Root Cause Analysis and Rapid Cycle Analysis of FDA BPDs.

• Performance improvement projects of laboratory.

• Perform testing on the Ortho ProVue as well as manual testing.

Committees:

• Key member of the Transfusion Alternative Program (Bloodless Medicine).

• Provide valuable input and ideas as a trauma committee member.

• Transfusion committee leader and facilitator

• As blood drive chairman, created new methods to increase donor turnout 233%.

• Provide laboratory guidance and influence of policies on the Patient Safety Committee.

EMORY UNIVERSITY HOSPITAL, Atlanta GA 2010 - Present

Center for Transfusion and Cellular Therapies - Medical Technologist II (2011-Present) Part-time

Utilize expanded blood banking techniques in a fast paced highly regulated environment including antibody identification, DAT’s, eluates, washing and irradiation of products, and crossmatching.

Highly skilled in automated testing including Immucor’s Galileo, Echo, Neo and manual capture systems.

Management of components, tissue products and coagulation factors for patients.

Lead Project Manager for conversion of temperature system for Emory system including OR.

Project Manager for Cryoprecipitate wastage project.

Progression toward leadership role as Medical Technologist III.

Molecular and Immunogenetics Laboratory - Medical Technologist II (2010-2011)

Performed HLA DNA typing and analysis for organ transplants and deceased donors.

AMERICAN RED CROSS, Atlanta GA 2008- 2010

Immunohematology Reference Laboratory - Lead Project Manager/Medical Technologist

Lead Project Manager for successful resumption of activities project for reference laboratory (2010).

Completed extensive training for Six Sigma Greenbelt (Toledo, Detroit, 2010).

Leader and Project Manager for Six Sigma Greenbelt Projects.

Key lean/process improvement team member for reference laboratory.

Performed advanced manual and automated blood banking techniques for transfusion services.

Primary user and trainer for Immucor Galileo.

UCB, INC, Smyrna, Georgia 2007 - 2008

Global Medical Affairs - Clinical Trial Assistant

Managed clinical trials within time and budgetary requirements ensuring compliance with GCP, SOP’s and all applicable regulatory requirements. Reviewed informed consent templates, protocol amendments, monitoring guidelines, case report forms and guidelines, laboratory specifications and manuals, IVRS specifications, trip reports, clinical trial agreements, consulting agreements, confidentiality agreements and regulatory documents. Attended and presented CRA training at investigator meetings, kick off meetings, face to face meetings with CRO and CRA meetings.

Ensured Federal guidelines were followed in adverse event situations by coordinating the distribution of IND safety to clinical sites and Internal Review Boards.

Assured all ICH essential documents were available in order to gain “regulatory release.”

Assisted in the preparation of regulatory submissions to the United States (FDA) and globally.

Created and maintained designated trial tracking systems (TMF) with trial requirements to ensure accuracy and completeness of information gathered (essential documents, investigator contract, site activities, vendor activities, monitoring visit reports).

Recognized as “super user” of the Clinical Trial Management System, Business Objects and IMPACT

Key role in creating and maintaining the accuracy and completeness of the study budget (Grant Plan).

Selected to attend site initiation monitoring visit (SIV) to observe protocol adherence.

Instrumental in representing the laboratory in selection of Central lab, IVRS and CRO rheumatoid arthritis study. Member of feasibility, site activation, and IND safety reporting subteams. Updated website study information for Clintrials.gov.

QUINTILES TRANSNATIONAL LABORATORIES, Smyrna, Georgia 1998-2007

Project Management - Project Coordinator (2006 – 2007)

Acting Global Project Manager for Oncology (Leukemia) Study in 25 Countries. Ensured smooth operation and monitoring of 15 global clinical trials. Provided continuity for support for investigator sites, sponsors and Contract Research Organizations.

Provided input regarding design and launch process improvements. After study launch, assist with the review, approval, execution and redesign of all changes made to the various clinical trial studies.

Honored with 3 Star awards for excellent customer service

Project Management - Project Set-Up Specialist (2003 – 2006)

Key role in designing, loading and validating clinical research protocols and databases. Coordinated information and communications for designated projects, including internal and external correspondence.

Configured the project specific database for top pharmaceutical companies. Validated, prepared and updated the protocol-specific documents and scope of work.

Provided expertise on database configuration and study design, leveraging laboratory background.

Assisted with review, approval, execution and redesign of changes made to clinical trial studies.

Medical Technologist (1998- 2003)

Leader of hepatitis/serology department. Performed all hepatitis and HIV testing such as HBsAG, HCV, AUSAB, Be antigen, Anti-Be, Core, HIV 1/2, and Delta testing (Elisa and Bioassay). Performed RPR's, chemistries, special chemistries and electrophoresis. Tested viral load count for hepatitis and HIV using molecular PCR DNA testing.

Instrumental in the development of Anti-Nuclear Antibody (ANA), Double Stranded DNA (dsDNA) and ANCA program at Quintiles Laboratories by single handling bringing one of the top pharmaceutical companies to Quintiles.

Earned 3 Technical Service Awards and Standing Ovation Award for bringing top client to Quintiles

AMERICAN RED CROSS, Atlanta, GA and New York 1991- 1998

Medical Technologist

Performed blood banking techniques such as cross matching, antibody identification and transfusion services. Worked all areas of serology (Bioassay) department including hepatitis and HIV 1/2.

EDUCATION AND TRAINING

Master’s of Health Services with Concentration in Community Health

California College of Health Sciences - National City, CA

BS in Biology- State University of New York at Oswego - Oswego, NY

AFFILIATIONS

Medical Technologist, American Medical Technologists (87633

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