BioPhase
Inhouse Clinical Research Associate
BioPhase, San Francisco, California, United States, 94199
Overview
In-House Clinical Research Associate (CRA) to support early- and late-phase clinical trials in a fast-paced biotech setting. Central to study operations, vendor oversight, and ensuring quality and compliance from start-up through close-out. Base pay range
$50.00/hr - $65.00/hr Responsibilities
Manage site feasibility, selection, start-up, and close-out documentation. Maintain CTMS and study trackers to monitor site activation, enrollment, and performance metrics. Support remote site monitoring, review reports and ICFs, and track resolution of issues with field CRAs. Serve as point of contact for select vendors, review reports for accuracy, and track performance. Maintain eTMF to inspection readiness and support cross-functional study communication. Qualifications
Bachelor’s in life sciences (or related field) preferred; Associate’s with relevant experience considered. 1–3 years’ clinical research experience, ideally in biotech or sponsor settings. Knowledge of GCP, ICH, and regulatory requirements. Proficiency with Veeva Vault, EDC, IRT, CTMS, and Microsoft Office. Strong organizational, communication, and problem-solving skills. Willingness to travel domestically up to 20%. Employment type
Full-time Job function
Research Industries
Biotechnology Research and Pharmaceutical Manufacturing
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In-House Clinical Research Associate (CRA) to support early- and late-phase clinical trials in a fast-paced biotech setting. Central to study operations, vendor oversight, and ensuring quality and compliance from start-up through close-out. Base pay range
$50.00/hr - $65.00/hr Responsibilities
Manage site feasibility, selection, start-up, and close-out documentation. Maintain CTMS and study trackers to monitor site activation, enrollment, and performance metrics. Support remote site monitoring, review reports and ICFs, and track resolution of issues with field CRAs. Serve as point of contact for select vendors, review reports for accuracy, and track performance. Maintain eTMF to inspection readiness and support cross-functional study communication. Qualifications
Bachelor’s in life sciences (or related field) preferred; Associate’s with relevant experience considered. 1–3 years’ clinical research experience, ideally in biotech or sponsor settings. Knowledge of GCP, ICH, and regulatory requirements. Proficiency with Veeva Vault, EDC, IRT, CTMS, and Microsoft Office. Strong organizational, communication, and problem-solving skills. Willingness to travel domestically up to 20%. Employment type
Full-time Job function
Research Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr