Clinical Trial Associate
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
The Clinical Trial Associate is responsible for the support and coordination of clinical operations activities. The CTA will interact with the Dynavax Clinical Operations and the cross functional team; collaborate effectively with CROs, consultants, vendors, and clinical trial sites; and assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures.
The CTA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational and communication skills.
- Act as the clinical link to clinical operations team, clinical research associates, vendors, and investigational sites
- Maintain timely and effective communication among team members and site staff; partners with the cross functional team, e.g., regulatory, medical, quality assurance, as needed
- Responsible for the receipt, processing and tracking of temperature excursion reports
- Track monitor visits, monitoring/site visit reports and site documentation submitted by CRAs according to monitoring plan and/or SOP requirements
- Track and support maintenance of key study performance indicators for sites, e.g., participant enrollment, SAEs, etc.
- Assist with site start up activities, such as: collect, review, and assemble site essential regulatory documents according to study procedures and SOPs
- Maintain current regulatory documentation according to essential regulatory document guidelines and Trial Master File (TMF) plan
- Submit/track protocols, amendments, change in research submissions to IRBs/ECs
- Assist with the establishment of TMF specifications, TMF study-specific plans, expected documents list and ongoing submission of documents to the TMF
- Serve as clinical TMF subject matter expert, support the central filing of study documents and functional area QC reviews of the TMF documents
- Assist with the development of study-specific document tracking systems to ensure the collection and maintenance of required documents
- Assist with the review and editing of clinical documents to ensure accuracy, consistency, and regulatory compliance
- Assist with the preparation of study start up materials and tools, as requested
- Attend clinical monitoring staff meetings and clinical training sessions
- Assist with scheduling of meetings and draft meeting minutes as requested
- Order and assemble study supplies and patient retention materials such as ID cards, appointment cards, IBs, Protocols and Regulatory Binders
- Perform other work-related duties as assigned
- Demonstrate basic understanding of SOPs, FDA, and local regulations as well as ICH Guidelines
- Demonstrate basic understanding and knowledge of ongoing protocols and disease-related terminology for studies
- Basic knowledge of drug development process
- Travel may be required (up to 10%)
- Working knowledge of FDA regulatory requirements and ICH GCP
- Requires strong organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Excellent written and oral communication skills, strong computer skills (Excel, Word, PowerPoint) and solid presentation skills
- B.A/B.S. degree in the science/health care or other relevant field
- 2+ years of clinical research experience, biotech or other relevant field is preferred, Pharmaceutical or relevant CRO experience is required, experience with vaccine clinical trials a plus