Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
Serves as the primary liaison with sponsors, Investigational Drug Service (IDS), and other parties as necessary.
Follows protocol schema for randomization and blinding and unbinding.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings.
Conducts activities for study visits in compliance with the protocol.
Conducts and documents consent for participants for all types of studies, including those that are complex in nature and require any orders in Maestro Care.
Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
Recognizes data quality trends and escalates as appropriate.
May develop tools for, and train others in, data quality assurance procedures.
Collects appropriate information to determine whether the study teams participation in a specific trial is feasible.
May make feasibility recommendations.
Requirements
Completion of an Associate’s Degree
A minimum of two years of relevant research experience
A Bachelor’s degree may substitute for two years required experience
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers)
Benefits
health insurance plans
generous paid time off
retirement programs with employer contributions
tuition assistance for employees and their children
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data quality assurancestudy monitoringprotocol compliancerandomizationblindinginformed consent documentationdata accuracydata trackingfeasibility assessment
Soft skills
communicationorganizationalproblem-solvingattention to detailtraining