Clinical Trial Associate (Contractor Part-time)

This position can be 100% remote.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B®, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines. 

At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary.  Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany.  

The part-time Clinical Trial Associate (CTA) contractor will assist with the 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 ensure adherence to Good Clinical Practice (GCP), investigator integrity and compliance with all study procedures.

The CTA supports the timely conduct of clinical studies according to protocols, 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 a clinical link to clinical operations team, clinical research associates, vendors, and investigational sites
• Assist with timely and effective communication among team members and site staff; partner with the cross functional team, e.g., regulatory, medical, quality assurance, as needed 
• Work in collaboration with the clinical operations team to help develop study-specific plans and manuals
• Support tracking of monitoring visits, monitoring/site visit reports and site documentation submitted by CRAs according to monitoring plan and/or SOP requirements
• Gather, track and support maintenance of key study performance indicators for sites, e.g., participant enrollment, SAEs, etc.
• Participate in site start up activities, such as: collect, review, and assemble site essential regulatory documents according to study procedures and SOPs
• Manage current regulatory documentation according to essential regulatory document guidelines and Trial Master File (TMF) plan
• Assist with submission and tracking of IRB/EC submissions of protocols, amendments, etc.
• Review and assist with drafting TMF specifications, TMF plans, expected documents list and ongoing submission of documents to the TMF
• Perform central filing of study documents and functional area QC reviews of TMF documents
• Participate in 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
• Participate in the preparation of study materials and tools, as requested
• Manage clinical and cross-functional meetings and clinical training sessions
• Schedule 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
• Travel may be required – up to 10%.
• Other duties as assigned.

• A BA/BS degree in Life Sciences or equivalent 
• 3+ years of clinical research experience, biotechnology industry or other preferred
• Working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials
• Strong organizational, documentation and interpersonal skills
• Excellent written and oral communication skills
• Experience working in cross-functional project teams
• Willingness to work in a team-oriented environment
• Strong verbal and written communication and interpersonal skills
• Computer proficiency a must (Excel, Word, PowerPoint)
• Ability to manage multiple tasks to meet deadlines in a dynamic environment
• 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
• Ability to sit; stand; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.

• Integrity and flexibility
• Proactive in identifying potential problems and seeking successful solutions
• Action- and goal-oriented
• Practical approach to clinical and regulatory processes
• Collaborative and team-oriented
• Excellent attention to detail

• This is a contract, part-time position that requires 20-30 hours per week. This is not a full-time position.

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Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.