Pharmaceutical Clinical Associates, LLC
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Raritan ,
NJ
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1 Design, validate and implement bioanalytical methods used to identify the appropriate dose and dosing regimen of therapeutic products.
2 Assist in establishing appropriate pharmacodynamic analytical methods
3 Prepare and perform bioanalytical analyses on clinical trial samples and summarize data in technical memos and/or study reports.
4 Author standard operating procedures, validation protocols and reports to reflect laboratory practice
5 Maintain all necessary laboratory documentation that pertain to the assay of samples
6 Perform routine laboratory maintenance activities
7 Extract data from clinical databases
8 Perform Quality Control audit of data, forms and databases
Experience and Skills:
1 B.S. in a biological science or pharmacologic discipline.
2 5+ years experience in a clinical research laboratory, biopharmaceutical industry or basic research laboratory preferred.
3 Excellent verbal and written skills. Ability to communicate across functional areas (clinical, regulatory and manufacturing).
4 Ability to work within a team environment and willingness to contribute to the overall goals of the Clinical Pharmacology group.
5 Familiarity with laboratory information management systems (Watson), Laboratory Automation (Biomek) and data analysis software (Winonlin, JMP)
6 Ability to understand and follow Standard Operating Procedures
7 Ability to work with little supervision as well as direct support lab personnel.
8 Knowledge of biosafety procedures for handling human blood and its components.
9 Practical knowledge of immunology based assays including but not limited to ELISA, ECLA, BiaCore analysis. Practical knowledge of immunogenicity assay.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: Masters Degree
Salary: $ 60,000 to 70,000
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan , NJ
Raritan , New Jersey
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