Real Staffing
http://www.realstaffing.com
http://www.realstaffing.com
Protocol Writer - Scientist II
Job type: Perm
Salary: Negotiable
Location: Nebraska-Lincoln
Due to the expansion of the Clinical Pharmacology team, a world-famous CRO is seeking a Protocol Writer and Scientist based near Lincoln, NE. This role is responsible for the development of protocols incorporating proper study design based upon scientific research and regulatory requirements as well as being responsible for the development of protocol designs as required.
This company is international and will be able to provide strong international leadership opportunities down the line.
Job Description:
-Report into an international team under clinical pharmacology directly under the head of protocol development and design
-Write protocols for client review and approval using FDA, EMEA or Health Canada Guidance’s, client information, drug/medical references, literature searches, and in-house data etc.
-Coordinate with study nurses, investigators to ensure IRB stipulations are correctly addressed and in a timely matter
-Track and assist complete protocol lifecycle requirements (i.e. continue review applications/bioethics reviews, protocol amendments, DSMB reviews)
Minimum Requirements:
-Minimum of BS in a scientific field required
-PharmD, RN, PHD or MS preferred
-Strong knowledge in study design, pharmacology and pharmacokinetics
-Knowledge of GLP, FDA, EMEA, TPD, GCP and ICH guidelines and regulations
Please send all resumes to Dandan Zhu at 212-707-8499! Submit today! Don’t miss out this excellent opportunity to be part of an international team!
This company is international and will be able to provide strong international leadership opportunities down the line.
Job Description:
-Report into an international team under clinical pharmacology directly under the head of protocol development and design
-Write protocols for client review and approval using FDA, EMEA or Health Canada Guidance’s, client information, drug/medical references, literature searches, and in-house data etc.
-Coordinate with study nurses, investigators to ensure IRB stipulations are correctly addressed and in a timely matter
-Track and assist complete protocol lifecycle requirements (i.e. continue review applications/bioethics reviews, protocol amendments, DSMB reviews)
Minimum Requirements:
-Minimum of BS in a scientific field required
-PharmD, RN, PHD or MS preferred
-Strong knowledge in study design, pharmacology and pharmacokinetics
-Knowledge of GLP, FDA, EMEA, TPD, GCP and ICH guidelines and regulations
Please send all resumes to Dandan Zhu at 212-707-8499! Submit today! Don’t miss out this excellent opportunity to be part of an international team!
Reference: 1371997
Contact name: Dandan Zhu
Email: permanent.nyc@realstaffing.com
Contact no: +1 212 707 8499
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