We are currently seeking a Clinical Trial Associate to join an amazing opportunity to be involved in a top notch pharmaceutical company, where you will be applying your prior experience to this new and exciting position.
Our client, a vibrant and growing player in their field, invites potential candidates to involve themselves in their latest research study. As a member of their community, you will be providing support for the planning, execution, and financial aspects of the project.
- Assist as needed with the general work of keeping up with clinical functions as they intersect with other functional areas.
- Responsible for oversight of vendors/consultants, which includes communicating timelines, negotiating contracts, preparing purchase requisitions, and coordinating related activities.
- Assist in the development, maintenance, training, and record keeping Clinical SOPs and guidelines in accordance with GCP, ICH, and FDA Guidelines.
- Actively participate in design, development, and review of study protocols, reports, and case report forms to ensure compliance with GCP, ICH, and FDA guidelines.
- Provide management support for activities with outside vendors and business partners, as required.
- Support preparation activities for FDA and other applicable regulatory body meetings
- Travel may be required (up to 30% of the time) based on department needs
- Reports study metrics and other critical information to project management using study trackers, data forms, and report
- Assists Clinical Project Manager (CPM) with the tracking and review of safety events
- Assists in the development of critical study documents, including clinical protocols, ICFs, operational documents, study reference documents, study newsletters, site materials, and other study-related documents
- Provides vendor management support to CPM
- Assists data management, CPM, and monitors by driving site data entry and query resolution
Experience & Skills Required
- High energy individual able to effectively multi-task, priority set, and strive in a dynamic environment.
- Excellent communication (oral and written), organizational, and problem-solving skills.
- Able to quickly grasp concepts and instructions
- Individual will possess attention to detail, requiring little revision to work produced
- Overall understanding of early to late stage clinical trial process
- Strong attention to detail
- Prior experience in monitoring clinical trials and data.