Clinical Trial Assistant
Emeryville, CA | Contract
Bayside Solutions is seeking a Clinical Trial Assistant to be part of our Client’ s team in Emeryville. This is an opportunity to work with a Global healthcare company focusing on improving the health and well-being of people around the world.
Our client is a Global sponsor company that develops innovative diagnostic therapies designed for hospitals, laboratory professionals and healthcare providers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Trial Assistant
The Clinical Trial Assistant will provide general administrative support to the Clinical Operations Department. He/she will be responsible general study management and clinical monitoring support, study tools/supply management, document coordination, sample management, and clinical system support.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Assist with preparation, planning, execution, and close-out of clinical trials
- Prepare for and participate in team meetings and generate meeting minutes
- Assist with the development of study-specific instruction manuals/ guidelines
- Create and ship investigator site binders to trial sites
- Assist with ordering and tracking of investigational product and clinical supplies
- Contact clinical sites for specific requests (e.g., updates, missing documentation, meeting arrangements, etc.)
- Maintain tools to support study (e.g., logs to track investigational product kits, samples, supplies)
- Assist CRAs with collection, review and tracking of essential documents
- Act as Document Coordinator responsible for creating and maintaining Trial Master File (TMF)
- Scanning, filing, and retrieving clinical trial documents for/from the TMF
- Perform quality control checks on clinical trial documents and TMF
- Manage sample shipment, receipt, handling, and storage. Shipments may include biohazardous materials
- Assist with the entry/tracking of data/samples in clinical databases and other associated data tracking tools, if applicable
- Assist CRAs with in-house and on-site monitoring visit activities, if applicable
- Coordinate with external vendor/sites, if applicable
- Assist in co-ordination of site payments, if applicable
- Perform additional project tasks as determined by department and organizational needs
- General administrative tasks
- Bachelor’ s degree in a medical or medically-related field and/or equivalent experience preferred
- Minimum 0-2 years of experience
- Basic knowledge of clinical trials
- Able to follow instructions
- Effective time management, organizational skills and ability to manage multiple tasks
- Meticulous attention to detail and accuracy
- Working knowledge of technical computer systems
- Highly proficient in MS Office Suite such as Word, Excel and PowerPoint
- Ability to use EDC systems preferred