BioPhase
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This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $70.00/hr - $90.00/hr
Direct message the job poster from BioPhase
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 Pacific Time Zone (preferably San Francisco, CA) 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!
Seniority level Mid-Senior level
Employment type Contract
Job function Research and Consulting
Referrals increase your chances of interviewing at BioPhase by 2x
#J-18808-Ljbffr
This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $70.00/hr - $90.00/hr
Direct message the job poster from BioPhase
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 Pacific Time Zone (preferably San Francisco, CA) 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!
Seniority level Mid-Senior level
Employment type Contract
Job function Research and Consulting
Referrals increase your chances of interviewing at BioPhase by 2x
#J-18808-Ljbffr