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Manager Clinical Research

Location:
Blairsville, Georgia, 30512, United States
Posted:
May 23, 2018

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Resume:

Teresa Danner M.L.T

License # TC*****

L

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

Blairsville, GA 30512-4627

ac5k1i@r.postjobfree.com

Professional Experience

Public Relations Associate

*/**** ** *******

Priority Health Rx

CEO: Mark Brown

Phone: 855-***-****

Development of PR campaigns.

Collaborate with the CEO to implement strategies for increased Clients.

Talks to Clients to explain the benefits of joining our programs and upload there information in our system so we can start servicing their Medication List.

Follow up with Clients to ensure they are happy with our services.

Addresses any issues with the CEO and when necessary with the team.

Laboratory Manager

1/1/2010 – 09/2017

West Orange Nephrology

Laboratory Director: Dr. Banji Awosika

Phone: 297-8408

Administrates and supervises the technical and scientific operations within the Clinical Laboratory.

Oversees Preventative Maintenance, Quality Control and Quality Assurance Measures.

Ensures the Lab meets all requirements for State, Cola, OSHA and National Accreditations.

Reviews and approves all new procedures and facilitates training of the Laboratory Staff.

Development and Verification of all new Laboratory assay procedures and placement that include Calibration Verification, Linearity Studies and Correlation Studies.

Establishing employee Competency outlines to ensure consistent accurate results.

Troubleshooting instrumentation errors through Levy Jennings charts to identify any Shifts and Trends of a failing assay.

Remedial actions are taken and documents whenever any variations from establishes performance specifications occur.

Cost per test evaluations and Insurance reimbursement studies.

Budget and forecasting of Laboratory profits.

Yearly training of OSHA Guidelines which include:

Use of universal precautions, Consideration, implementation, and use of safer, engineered needles and sharps. Use of engineering and work practice controls and appropriate personal protective equipment (gloves, face and eye protection, gowns) Hepatitis B vaccine provided to exposed employees at no cost Medical follow-up in the event of an “exposure incident”. Use of labels or color-coding for items such as sharps disposal boxes and containers for regulated waste, contaminated laundry, and certain specimens. Employee training. Proper containment of all regulated waste as well as maintain the required records of disposal

Clinical Research Associate

May 2015 – Feb. 2017

Omega Clinical Research

Director: Dr. Harry Nyanetch

Phone: 386-***-****

Collect and organize data obtained during studies and trials conducted in fields, such as biotechnology and pharmaceuticals.

Coordinate and process results gained from long-term testing of drugs, products and medical procedures as set in the trial guidelines.

Data collection forms, known as case report forms (CRFs).

Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

Applications and approvals that oversee the research and marketing of new and existing drugs.

Identifying/selecting the Primary Investigator who will be responsible for the conduct of the trial at the trial site.

Liaising with doctors/consultants or investigators on conducting the trial.

Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards.

Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis.

Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).

Reporting and Collecting completed CRFs from hospitals and general practices.

Writing visit reports and filing and collating trial documentation and reports.

Discussing results with trial monitors.

Archiving study documentation and correspondence.

Technical Consultant (Independent)

November 2009 - 2011

Instrument placement.

Training of Laboratory testing personnel.

Validation studies of assays to include Calibration Verification, Linearity Studies and Correlation Studies.

Responsible for the technical and scientific oversight of the laboratory.

Specific account details available upon request.

POL – Personnel Management Program

Quality Assessment Plan

General Laboratory & Procedure Manual

Laboratory Manager – Consultant

March 2006 – Sept. 2009

Nephrology Associates of Central Florida

Laboratory Director: Dr. Howard Sackel

Phone: 407-***-****

Brought on to this account as a Technical Consultant to bring the Laboratory out of

Probation status given by the State of Florida

Ran samples and maintained a QC and QA program for 11 doctors and 3 locations.

Start up on a ground level laboratory

Establishing linear ranges of assays

Training of testing personnel

Development and implication of laboratory policy and procedures

CLIA, State of Florida and OSHA compliance

Lab was reinstated as a full moderate Complexity testing Laboratory as of 2006

Laboratory Supervisor

Nov. 1995 Feb.2006

Cancer Institute of Florida

Phone: 407-***-****

Laboratory Director: Dr. Linda Lukman

Specimen Processing, test performance verifications.

Slide review and cell identification and differential

Assisting Physicians in Bone Marrow and Biopsy procedure.

Responsible for assuring compliance with applicable regulations (State of Florida, Clia and Cola.

Selection of methodologies with the capacity of providing quality results required for prompt patient care.

Maintain verification programs that include Levy Jennings Linear review, Correlation Studies and Proficiency Testing.

Laboratory Generalist

1987-1995

Florida Hospital

East Altamonte Drive, Altamonte Springs, FL 32701 Phone: 407-***-****

Working in all areas in the Lab: Hematology, Chemistry, Blood Bank and Microbiology.

Assist Pathologist in Slide and Tissue preparation for Pathology Review.

Maintaining instrument maintenance.

Problem identification and resolution.

Student

1984-1986

Medical Laboratory Technology program as a generalist in Hematology, Serology, Chemistry, Blood Banking, Microbiology and Serology.

Florida Hospital South

601 St Rollins Street, Orlando, FL 32803

Phone: 407-***-****

Florida Hospital North

601 East Altamonte Drive, Altamonte Springs, FL 32701

Phone: 407-***-****

Orlando Regional Medical Center

1414 Avenue, Orlando, FL 32806

Phone: 321-***-****

Central FL-Blood Bank Inc.

32 W GORE ST

ORLANDO, FL 32806

Phone: 407-***-****

References:

Mark Brown: 407-***-****

Dr. Linda Lukman: 407-***-****

Sue Nerud: 612-***-****

Graham Mafela: 765-***-****



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