Contractor Senior Clinical Research Associate

This position is 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.

The Senior Clinical Research Associate (CRA) contractor will perform and coordinate all aspects of clinical monitoring and site management to ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs, and overall clinical objectives.

1. Lead evaluation and selection of sites, manage investigative sites; oversee CRO monitoring activities to ensure oversight of site compliance.
2. Serve as the point of contact for monitoring activities of study data verification on source documentation and case report forms (eCRFs) to ensure compliance with study protocols, GCP, and SOPs.
3. Ensure data discrepancies are efficiently identified and resolved.
4. 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.
5. Identify noncompliance and implement preventative and corrective actions, and escalate issues to the clinical project manager.
6. Communicate with investigators, colleagues, and vendors ensuring clinical quality and compliance.
7. 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.
8. 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.).
9. Evaluate metric data to identify areas needing or showing the effectiveness of process improvements.
10. Actively participate in sponsor oversight and study execution, including clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
11. 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.
12. May be the lead clinical operations representative in study and/or project team meetings.
13. Lead review of clinical data listings for accuracy, partner with data manager to resolve discrepancies quickly.
14. Review monitoring visit reports and track resolution of action items.
15. Develop and implement enrollment and recruitment strategies.
16. Manage and facilitate the implementation of study systems and technology including EDC, IRT, eDiary, eTMF, CTMS, PROs, etc.
17. Support activities related to the preparation of study protocols, clinical sections of INDs, and other regulatory submissions as needed.
18. Support the planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.).
19. Daily activities may vary depending on the clinical phase of the program and this role may support more than one study.
20. Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
21. Travel is required – up to 25%.
22. 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 biotechnology industry, sponsor experience preferred.
• On-site monitoring proficiency required.
• 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.
• Excellent technical writing skills.
• Proven experience working in cross-functional project teams.
• Excellent verbal and written communication and interpersonal skills.
• Computer proficiency a must.
• Experience mentoring more junior CRAs and CTAs preferred.
• 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.
• Integrity and flexibility.
• Proactive in identifying potential problems.
• Action- and goal-oriented.
• Practical approach to clinical and regulatory processes.
• Collaborative and team-oriented.
• Excellent attention to detail.

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