Clinical Trial Assistant
1035 O'Brien Drive Menlo Park, CA 94025
Clinical Trial Assistant
**LOCAL CANDIDATES ONLY**
We are currently seeking a qualified, highly motivated, experienced individual for the position of Clinical Trial Assistant (CTA) to join our team supporting management of sponsored clinical trials. The primary focus of this in-house CTA position is to provide administrative and project specific support related to the conduct of clinical trials and archiving of clinical trial documents, including assistance with project management activities, performing administrative duties required to run the clinical development programs. Familiarity with FDA regulations and ICH/GCP guidelines is plus.
CORE JOB RESPONSIBILITIES
- The primary role of the CTA is to support the logistical aspects of clinical trial conduct in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
- Work closely with other members of the Clinical Team to support activities during a study startup, study execution and close out phases.
- Conduct periodic review and tracking of all clinical trial deliverables and all applicable metrics
- Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to SOPs and study requirements, as well as periodic review of study files for accuracy and completeness.
- Support the preparation, handling and distribution of clinical trial correspondence and study supplies related to biospecimen collection, processing, shipment, and storage, as well as maintenance of associated tracking information and management of external vendors.
- Assist with the tracking and management of queries and clinical data flow as needed.
- Facilitate and document the internal project meetings, draft internal and external correspondence and file the associated documentation.
- Facilitate flow and maintenance of correspondence with contract service providers.
- Participate in internal and external team meetings.
- Set up and coordinate meetings, prepare and distribute meeting materials and meeting minutes.
- Set up and maintain Trial Master File (TMF) and tracking tools.
- Assist in contacting investigative sites to provide study-specific information.
- Assist in preparation, tracking and distribution of materials.
- Assist in review and development of clinical study documents and tools.
- Assist in clinical trial supplies management and distribution.
- Collect regulatory/essential documents as applicable.
- Assist with review of clinical study data and documents for quality control purposes.
- Prepare and draft of clinical study newsletters.
- Maintains knowledge of regulations, guidelines, policies and practices for conducting of clinical trials.
- Travels as required to carry our responsibilities.
- Provide administrative support.
- Performs other duties as assigned by manager.
- BA/BS degree, minimum 2 years of work experience in clinical research or relevant field preferred qualification
- Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines preferred Experience supporting clinical study operations, including studies involving development of therapeutics, medical devices, or diagnostics;
- Familiarity with sample management, sample processing, and biobanking best practices
- Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint
- Ability to work independently and initiative are required.
- Strong written and verbal communication skills, effective time management and organizational skills attention to detail and accuracy in work ability to establish and maintain effective working relationships with coworkers, managers and clients