Senior Clinical Research Associate (Contractor)

This position can be 100% remote, but must be located in the United States. 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 Senior Clinical Research Associate (CRA) contractor will perform and coordinate all aspects of the clinical monitoring and site management process to ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives.

Responsibilities

• Lead evaluation and selection of sites, manage investigative sites; oversee CRO monitoring activities to ensure oversight of site compliance.
• Serve as the point for 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, oversight and co-monitoring with CRO, and close-out visits as needed.
• Identify noncompliance and implement preventative and corrective actions and escalate issues to the clinical project manager.
• Communicate with investigators, colleagues, and vendors ensuring clinical quality and compliance.
• Produce and manage reports that detail clinical study progress, such as subject screening and enrollment, source data verification, protocol deviations, safety events, monitoring progress/quality and other key performance indicators.
• Provide regular clinical status information to team members and clinical management; recommend and implement enhancements to clinical systems, guidelines, and processes; review work produced by the clinical team (e.g., trip reports, correspondence, tracking reports, etc.); evaluate metric data to identify areas in need of or effectiveness of process improvements.
• Actively participate in sponsor oversight and study execution, including clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out. 
• 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.
• May be the lead clinical operations representative in study and/or project team meetings.
• Lead review of clinical data listings for accuracy, partner with data manager to resolve discrepancies quickly.
• Review monitoring visit reports and track resolution of action items.
• Develop and implement enrollment and recruitment strategies.
• Manage and facilitate the implementation of study systems and technology including EDC, IRT, eDiary, eTMF, CTMS, PROs, etc.
• Support activities related to the preparation of study protocols, clinical sections of INDs, and other regulatory submissions as needed.
• Support the planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.).
• Daily activities may vary depending on the clinical phase of the program and this role may support more than one study. 
• 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.

Qualifications

• BA/BS in Life Sciences or equivalent; master’s degree preferred. 
• 4+ years of clinical research associate experience in the bi