Job Description

Under limited supervision, responsible for assisting with the administration, organization and implementation of trial operations, systems management, and training/education. Provides specialized and technical reviews of clinical trial research protocols, funding agreements and billing processes.

• Administers, organizes and conducts training/educational programs in connection with clinical trial operations, systems and management.
• Maintains records of training activities, progress, and program effectiveness.
• Ensures distribution and maintains inventory required for execution of research protocol(s).
• Assists in the determination of guidelines for new protocols.
• Collects and prepares data for various clinical trial related reports.
• Compiles reports, documents and correspondence for regulatory agencies, participating clinical trial sites and internal departments to monitor and evaluate progress.
• Develops, coordinates and conducts training in collaboration with clinical trial subject matter experts.
• Serves as liaison between clinical trial management systems end users and management systems support team.
• Performs all other duties as assigned.

• Knowledge of scientific concepts related to the design and analysis of clinical trials.
• Knowledge of data collection and management methodologies of clinical trial.
• Ability to demonstrate excellent written and verbal communication.
• Proficiency with computers, including Microsoft Office.

EDUCATION:

Bachelor's Degree degree in related field is required.

PREFERRED:

IRB experience, regulatory affairs experience, and clinical trials experience,