Senior 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.
Independently manage all aspects of assigned clinical studies to ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives. Develop protocols, investigator brochures, and study reports, and assist in new drug applications.
- Daily activities may vary depending on the clinical phase of the program and may support more than one study.
- Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget, and in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives.
- Drive all study parameters, including clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Oversee 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.
- Supervise and participate in on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Manage the review and approval of site visit reports.
- Manage activities related to 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.
- Manage and facilitate the implementation of study systems and technology including EDC, IRT, eTMF, CTMS, PROs, etc.
- Lead evaluation and selection of sites and CROs, and planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc).
- Participate in preparation of study protocols, clinical sections of INDs, and other regulatory submissions.
- Assist in analysis of clinical trial data and prepare clinical study reports.
- May be the lead clinical operations representative in 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. Five (5) plus years of direct clinical research experience in the biotechnology industry, sponsor experience preferred
- On-site monitoring experience required, demonstrated proficiency in mentoring CRAs/CTAs a plus
- Deep working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials
- Proven ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches
- Excellent technical writing skills
- Proven experience working in cross-functional project teams
- Experience with successfully managing multiple teams, external sites, and projects in a dynamic environment
- Excellent 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.
- 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.