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Reference Number:
N346434-Sci-NJ
Job Description:
Please send your MS Word format resume to ashish@mysunrisesys.com OR Call at 866-604-4591
Reply with location, availability, rate, visa status
Preferred Local Candidates, Face To Face Required
For Our Fortune 50 Client
Job Title: Clinical Research Scientist with Data Review / Cleaning
Duties:
The team is looking for highly motivated and pleasant individuals with previous experience in a global pharma company or those with experience in conducting a global study. We have a strong preference for those with a strong scientific or clinical background (i.e., oncology nurse, pharmacists, etc) and those with prior data management experience. This experience will be of help in the review of patient data and involvement with data cleaning activities. Furthermore, we are also very open to individuals with CRA experience and those who have been involved in study closure activities and/or preparation for health authority submission.
Scope of work
Primary work will be with clinical data review on patient profiles (PP) for GIST and CML
Review of usual safety parameters and appropriate cross-checks
Review of efficacy results according to RECIST Guidelines Version 2
# Assist CTH on follow up on audit findings
# Biomarkers database reconciliation
# Biomarkers sample tracking
# Communication with Data Management
# Contribute to data assembly for senior management, DMC, Steering committee
# Contribution to assembly of various documents for regulatory submission (SCE, SCS, CO etc)
# Contribution to CSR completion (body and appendices)
# Contribution to periodic safety review
# Contribution to PK reconciliation and sample tracking
# Coordination of drug destruction
# Coordination of extension roll-over
# CRA communication
# ECG management
# Involvement in TMF updates
# Potential involvement in third party database transfer
# Materials retrieval for sites that are closing (including third party materials as well)
# Narratives - data provision, coordination of narratives review and QC
# QC of various documents for regulatory submission
# Regulatory approval trackers
# Retrieval and clinical review of patient profiles
# Review of imaging data and contribution to imaging reconciliations (CT, MRI, PET)
# Review of patient using I-review
# Review of statistical outputs
# SAE reconciliation
# Tracking and identifying protocol deviations
# Tracking of essential documents
# Support of Tasigna project level activities if needed (flexibility required, if support on other studies is needed)
Skills:
Must have a scientific or clinical background (esp. oncology nurse etc.); or data management background who worked in oncology at least 2 years and knows to clean efficacy and safety related data as well
Education:
BA/BS or advanced degree Nurse or RPh would be ideal.
Please send your MS Word format resume to ashish@mysunrisesys.com OR Call at 866-604-4591
Experience Level:
Unspecified
Requirements:
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