Clinical Research Associate
US-Emeryville, CA OR Remote
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.
Under the direction of the clinical operations management, help to execute assigned clinical studies and ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives.
- Daily activities may vary depending on the clinical phase of the program and may support more than one study.
- Collaborate with contract research organization (CRO) personnel and study sites to ensure studies are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives.
- Support the study deliverables, including clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Assist with monitoring activities of study data verification on source documentation and case report forms (eCRFs) to ensure compliance with study protocols, GCP, and SOPs. Ensure data discrepancies are efficiently identified and resolved.
- Participate in on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Assist with the review and approval of site visit reports.
- Assist with the preparation of study-related clinical documents, including but not limited to: informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets, etc.
- Assist with the implementation of study systems and technology including EDC, IRT, eTMF, CTMS, PROs, etc.
- Support the selection of sites and CROs, and planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc).
- Support the review and development of study protocols, clinical sections of INDs, and other regulatory submissions.
- Assist with the review of clinical trial data and listings.
- Support the conduct and participate in clinical operations and project team meetings.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Travel is required – up to 25%.
- Other duties as assigned.
- A BA/BS in Life Sciences or equivalent, master’s degree preferred. 1 year of experience as a CRA, 2+ years of direct clinical research experience in the biotechnology industry, sponsor experience preferred
- On-site monitoring experience a plus
- Working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials
- Ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches
- Proficient technical writing skills
- Experience working in cross-functional project teams
- Strong verbal and written communication and interpersonal skills
- Computer proficiency a must
- Highly valued personal attributes include:
- 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
- Ability to stand or sit for prolonged periods.
- Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
- Occasional travel required, as needed.
- Full COVID-19 vaccination is required for this position.
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.