Clinical Trial Assistant


Position Summary:

The Clinical Trial Assistant is responsible for providing support to the lead CPM and the study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of own or others project goals and objectives. This person is able and willing to perform all duties or functions of subordinates. The core duties and responsibilities of the
Clinical Trial Assistant are delineated below.



Responsibilities, including but not limited to:
  • Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more study management teams (SMTs), scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs,tracking and managing distribution of non-clinical supplies throughout thecourse of the study
  • Tracks and maintains study information and reports on study progress
  • Tracks and provides IRB/IEC submission documentation and other supplementary documentation as appropriate
  • TMF Management: Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements
  • Serves as key central contact for communications, correspondence and associated documentation. Performs dutiessuch as, clinical form design, and filing of correspondence, lab reports, clinical monitoring reports, and other study documents
  • Maintains and ensures all documentation is in a state of audit-readiness
  • Responsible for collection, dissemination, and/or tracking of regulatory documents as required
  • Maintains accurate tracking and reporting of study management data
  • Coordinates study logistics, documents, drug shipments, enrollment and safety
  • Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards
  • Supports other projects as assigned
  • Coordinates Investigator and Study Coordinator meetings in collaboration with the Clinical Program Manager
  • Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
  • Coordinates communication for defined tasks and tracking information between the study team and vendor
  • Identifies and contributes to areas of best practice and process improvement

Requirements:
  • A Bachelor degree is required
  • 2+ years of experience, or extended education in clinical research/drug development
  • Familiar with concepts of clinical research and able to work effectively in a team environment
  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
  • Ability to deal with time demands, incomplete information or unexpected events
  • Must possess excellent Word, Excel and interpersonal skills
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports

 

Job Details

Job Type: Contract
Location: Brisbane, CA
Job ID: 21-03046
Date Updated: April 16, 2021