Ms. Caseta Mayers

** ****** **** ****, ****** Plains, NJ 07076

Home 908-***-****

Cell 848-***-****

E-Mail: abl2yx@r.postjobfree.com

OBJECTIVE: Seeking a challenging position in the field of clinical research in the pharmaceutical industry.

EDUCATION: B.S. Biology 2005, Montclair State University, Montclair, NJ

CERTIFY: Clinical Research Associates – In house

EXPERIENCE:

June 2014 – Qtech Solution Inc., Somerset, NJ.

Clinical Research Associates in-house

Trained on all aspects of site monitoring responsibilities for clinical trials.

Knowledge of phase I-IV clinical study including developing regulatory documentation.

Report status of clinical trial documents distribution, status retrieval of such as documents as per IB protocol etc.

Understanding of CRF’s preparing informed consent forms, and developing study documents in adherence to protocol and company SOP’s.

Experience with maintaining study specific trial master file. (TMF)

Knowledge of ICH and GCP guidelines, basic understanding of regulatory requirements.

Strong time management skills in handling multiple projects and deadlines under minimal supervision.

Can work independently or with the study team efficacy, highly self-motivated and a team player.

2008 – Present Plus Diagnostics Union, New Jersey

Molecular Technologist/Oncology

Independently perform routine and complex laboratory analyses for oncology trials.

Provides physicians with accurate and reliable analytical results for diagnosis of patients.

Assumes responsibility for procedural and system controls problem solving, teaching and supervision.

Experience in the health care industry performing clinical research and data.

Perform laboratory analysis using various software tools such as, Nova path, and vital-Axis.

Oncology Therapeutic DNA fish involves the precise annealing of a single stranded fluorescent labeled DNA probe with two complementary target DNA sequences in the sample cells.

Maintain records that demonstrate that proficiency testing samples are tested in same the manner as patient specimens.

Ensure regulatory compliance, quality and business ethics.

Manage project following CLIA, HIPAA, OSHA, and safety guidelines in the department for reporting STATS or critical results to clients.

2005 – 2007 Watson Pharmaceutical, Inc. Carmel, NY

Senior Microbiologist

Collected purified water samples from the various USP Purified water loops used to manufacture or test drug products. • Prepared media used in the microbiological testing of bulk pharmaceutical chemicals, drug products.

Conducted aseptic samplings for evaluation of compress air and cleaning validation process.

Collected environmental samples for microbiological analysis.

Executed testing of raw materials in process, finished products and stability product using established test methods to prove accurate and reliable data to assure strength, identity and purity.

Assured that data generated and reported is accurate, reliable, and reproducible.

Reviewed and released data entered into a computer based laboratory information systems

QUALIFICATIONS:

Performed separations by gas chromatography, purification, extractions, and distillations.

Knowledge of aseptic sterilization techniques, operated instruments such as the HNMR, Hemacytometer, pH Meter, Inverted microscope, Fluorescent microscopy, Incubator, Centrifuge, Autoclave, Gram stain testing & Calibrations, Pipetting, balance use.

Environmental monitoring, prepare media, perform microbial identification, raw materials

Purified water sampling, Carries out responsibilities in accordance with organization’s Policies, procedures, state and federal law Such as Occupational Safety Health Administration (OSHA), Material Safety Data Sheet (MSDS), Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Standard Operating Procedure (SOP’s) Computer Skills: Word, Microsoft Outlook, Internet Applications, Excel, PowerPoint and JMP

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