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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Scientist

Location: United States

Proclinical is currently recruiting for a Clinical Laboratory Scientist with a pharmaceutical company located in Rochester, NY. The Laboratory Scientist supports the Clinical Trials laboratory from testing to validation to quality and associated documentation.

Job Responsibilities:

Assists in instrument and method validations to support clinical trials for Hematology, Chemistry, Special Chemistry, and Flow Cytometry
Setup and maintenance of laboratory equipment in line with standard operating procedures (SOPs).
Performs appropriate quality control for reagents, equipment and assays, as assigned.
Analyzes validation and proficiency testing samples according to validation plans, timeline and standard operating procedures
Recognizes and documents any deviations from results, escalates issues to management as needed
Develops and writes standard operating procedures for instruments and methods as required
Review and quality checks validation documents for accuracy as required
Document and complete any quality documentation (Quality Issue, CAPA, deviation, change control) as appropriate within the required timeframes.
Participation in all activities that seek to ensure compliance with GCP guidelines and accreditation schemes (e.g. CAP, ISO, NYSDOH).

Skills and Requirements:

Bachelor's degree required; life sciences concentration preferred.
2+ years of laboratory experience in a clinical research environment preferred.
Experience with Good Clinical Practices (GCP), CLIA, College of American Pathology (CAP), and/or New York State preferred.
Strong organizational skills essential with the ability to multi-task and work efficiently.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-291-4181.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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