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Reference Number:
MS_CRS-EHNJ
Job Description:
Our major pharmaceutical client is looking for 4 Clinical Research Scientists for a 6+ month position in East Hanover, NJ.
** Candidates with the following backgrounds would be a good fir for these positions: Clinical Research Associates, Data Managers, Clinical Scientists. **
Adhere to Novartis clinical trial processes and align the biomarker procedures to be in compliance with these standard processes.
Work on a team with the TM Experts and Clinical Trial Leaders to develop the central and reference laboratory components to the biomarker assessments in clinical protocols. This activity consists of being responsible for all of the contracts and documentation required to set up central lab procedures, including signing the appropriate documents for the lab/kit set up. Activities to commence in a timely manner. This also includes serving as a member of the individual clinical trial teams (CTTs).
Work with the clinical study data managers to describe biomarker needs for the case record forms (CRFs) of the clinical study.
Ensure that the samples are being collected properly, documented accurately and timely shipped as set forth in the study protocols
Assist with setting up specific assessment data transfer needs.
Develop training material on the technical aspects of biomarker sample collections for the clinical sites as needed. This will include developing study specific lab manuals and site specific training needs.
Provide ongoing support to the clinical sites on the biomarker sampling procedures and central/reference lab questions.
Review sample associated demographic data and confirm consent if necessary to ensure that the correct samples are being analyzed or stored and that data is transferred as defined for the study protocol.
Address exploratory sampling ethical issues which may arise, including devising appropriate solutions which satisfy both ethical concerns as well as the study objectives.
Requirements:
- BS or MS in Biology or a related field -advanced degrees are not preferable for these positions.
- 2-3 years drug development experience, preferably in clinical research.
- General knowledge of biomarker discovery methodologies (molecular biology).
- Excellent organizational and communication skills.
- Ability to work in teams and function in a cross functional matrix organization requiring communication and training among clinical and biomarker colleagues.
- Basic knowledge of Good Clinical Practice and ICH guidelines.
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "CRS-EHNJ" IN THE SUBJECT LINE!
Experience Level:
Unspecified
Requirements:
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