Senior Clinical Research Associate

Summary

Join Dynavax, a biopharmaceutical company, as a Senior Clinical Research Associate (CRA) contractor. This 100% remote (US-based) position requires leading clinical monitoring and site management for clinical trials. You will oversee site selection, data verification, and on-site monitoring visits, ensuring compliance with GCP and regulations. Responsibilities include managing study documents, collaborating with cross-functional teams, and contributing to regulatory submissions. The role demands strong communication, technical writing, and problem-solving skills, along with experience in clinical research. Travel up to 25% is required. This is a contract position offering competitive hourly pay.

Requirements

• BA/BS in Life Sciences or equivalent
• 4+ years of clinical research associate experience in the biotechnology industry
• On-site monitoring proficiency
• 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
• Excellent verbal and written communication and interpersonal skills
• Computer proficiency
• 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

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

Preferred Qualifications

• Master’s degree
• Sponsor experience
• Experience mentoring more junior CRAs and CTAs

Benefits

• 100% remote (US-based)
• $80 - $80 an hour
• Travel is required – up to 25%