Temporary Clinical Trial Associate Job Description Template
Our company is looking for a Temporary Clinical Trial Associate to join our team.
Responsibilities:
- Supports other projects as assigned;
- Tracks and provides IRB/IEC submission documentation and other supplementary documentation as appropriate;
- Coordinates Investigator and Study Coordinator meetings in collaboration with the Clinical Program Manager;
- TMF Management: Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements;
- Coordinates study logistics, documents, drug shipments, enrollment and safety;
- Coordinates communication for defined tasks and tracking information between the study team and vendor;
- Maintains accurate tracking and reporting of study management data;
- Maintains and ensures all documentation is in a state of audit-readiness;
- Identifies and contributes to areas of best practice and process improvement;
- Tracks and maintains study information and reports on study progress;
- Responsible for collection, dissemination, and/or tracking of regulatory documents as required.
Requirements:
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required;
- Bachelor’s Degree is required;
- Ability to deal with time demands, incomplete information or unexpected events;
- Must possess excellent Word, Excel and interpersonal skills;
- Familiar with concepts of clinical research and able to work effectively in a team environment;
- Must have the ability to build and maintain positive relationships with management, peers, and direct reports;
- 2+ years of experience, or extended education in clinical research/drug development.