Assist Clinical Research Associates and Regulatory and Start-Up teams to ensure a complete and accurate Trial Master File delivery
Job Summary
Assist Clinical Research Associates and Regulatory and Start-Up teams to ensure a complete and accurate Trial Master File delivery.
Support clinical teams with preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to standard operating procedures.
May accompany Clinical Research Associates on site visits to assist with clinical monitoring duties upon completion of required training.
Matching Summary
Assist Clinical Research Associates and Regulatory and Start-Up teams to ensure a complete and accurate Trial Master File delivery.
Skills & Requirements
Must-have
Trial Master File management
Clinical document handling
Case Report Forms tracking
Clinical Trial Supplies management
Microsoft Word, Excel, PowerPoint skills
Good Clinical Practice awareness
Nice-to-have
Effective time management
Organizational skills
Strong written and verbal communication
Ability to maintain working relationships
Knowledge of ICH guidelines
Key Requirements
High School Diploma or equivalent
3 years administrative support experience
Awareness of clinical research regulatory requirements