1099 CRA Consultant

BioPhase specializes in recruiting top talented professionals for Scientific communities. We are currently looking for a REMOTE 1099 Clinical Research Associate Consultant to work for a leading San Francisco-based biotech company.

*Applicants must be located in the Mountain Time Zone (preferably Colorado or Utah) and able to work remotely.

*Ability and willingness to travel up to 50%, both domestically and internationally.

Responsibilities

• Serve as the primary sponsor representative during on-site monitoring visits, providing oversight of study conduct and data quality.
• Work collaboratively with CRO monitors and site teams to ensure studies adhere to protocols, GCP standards, and all regulatory requirements.
• Perform comprehensive data review and query resolution, supporting database lock activities to ensure data accuracy and integrity.
• Prepare and deliver concise, detailed monitoring reports in a timely manner following site visits.
• Maintain complete and accurate study documentation, ensuring compliance with company SOPs and industry standards.
• Partner cross-functionally with Clinical Operations, Medical Affairs, Biostatistics, and Data Management to facilitate effective communication and study progress.
• Oversee multiple oncology trial sites, proactively managing quality, compliance, and project timelines.
• Identify and implement opportunities to streamline processes and enhance sponsor oversight effectiveness.
• Participate in an on-site training session during onboarding and attend quarterly team meetings in San Francisco, CA.

Requirements

• Minimum 3 years of clinical trial monitoring or project management experience, ideally within oncology or drug development.
• Proven ability to conduct independent sponsor oversight visits for pharmaceutical, diagnostic, or medical device trials.
• Must have demonstrated CRO oversight experience, including review of CRO CRA work and quality deliverables.
• Ability to balance oversight with hands-on monitoring responsibilities as study timelines evolve.
• Thorough understanding of GCP principles, clinical protocols, and regulatory compliance.
• Skilled in data review, issue resolution, and database lock procedures.
• Strong communication, organization, and time management abilities.

What we offer:

As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

· Full support and career-development resources to help you reach your potential

· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Apply now and let's make work better!

www.biophaseinc.com