Day-to-Day Responsibilities
Reviewing the study protocol and statistical plan for a bioequivalence study that compares a generic product with the reference product
Coordinating with clinical sites, study volunteers and the sample-collection schedule
Checking the results of drug-level analysis from bioanalytical laboratories
Analysing pharmacokinetic data, such as how drug concentration in blood changes over time
Preparing study reports and the bioequivalence sections of regulatory submissions
Following Good Clinical Practice and Good Laboratory Practice standards and recording any deviations
Working with formulation scientists to explain why a generic product did or did not meet equivalence criteria


