Urgent requirement for one of our top clients located in “Branchburg, NJ”.
Please contact me at your earliest convenience, along with job No. CRA_53008 to xxxxxx.xxxxxx@xxxxxxxxx.xxx
Description:
Under general supervision, monitors one or more clinical oncology investigations, including initiating and closing investigational centers and collecting, processing, and reviewing case report forms. Under general supervision, assists with the overall planning, development, and data management of one or more clinical investigations, including the preparation, writing, and completion of required documents. Has a thorough understanding of FDA, ICH, and GCP regulations, guidelines, policies and practices for conducting clinical investigations. Aware of and follows company SOPs, GCPs, and ICH guidelines. Assists in the preparation and completion of IND, BLA, and NDA documents, as well as product annual reports and final safety reports.
Requirements:
Minimum of 1-2 years of progressively increasing clinical research experience within the biotech/pharmaceutical industry, oncology strongly preferred. Experience in drug development, especially FDA regulations and GCPs or Associates of Clinical Pharmacology CRA certification. A minimum academic degree in Nursing (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees.
Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) to *** xxxxxx.xxxxxx@xxxxxxxxx.xxx ***
Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.
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