Posted 16 days ago

Bioanalytical Principal Investigator - Small Molecule

LincolnOn-siteFull-time

AI Summary

A Bioanalytical Principal Investigator leads the bioanalytical execution for small molecule clinical studies, acting as primary client contact, reviewing protocols and data, approving plans and reports, and overseeing study personnel and deviations at a CRO.

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

Location: Corporate office in Lincoln, NE. Just south of downtown.

As a Bioanalytical Principal Investigator, you will have overall responsibility for the technical conduct of the bioanalytical portion of studies. This role is with our Small Molecule team.

Essential Functions:

Serve as primary client contact for the bioanalytical segment of studies

Review protocol and assure study is conducted in accordance with Protocol

Document and report any deviations from the protocol to Study Director or Sponsor

Review and approve Sample Analysis Plans

Assure all experimental data is accurately recorded and verified

Assure corrective action is taken and documented when necessary

Review and approve all project-related QA audits

Approve and document any bioanalytical deviations

Review and approve all bioanalytical reports

Assure all study personnel have adequate training, education and experience to perform required study functions

Conduct impact analysis of bioanalytical deviations

Oversight of Event Investigation reports

Requirements:

Minimum of a Bachelor's degree or equivalent in a science-related field with 5 or more years of industry experience preferred

5 or more years of previous laboratory and/or regulated bioanalysis knowledge preferred

Bioanalytical Principal Investigator - Small Molecule

About this role

Essential Functions:

Requirements:

Skills

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