Senior Clinical Research Associate
BioPhase Inc.
- Role type: Contract (likely end date of Dec 2027)
- Location: 3 days onsite in San Francisco, CA
Seeking an experienced Senior CRA to support clinical trial execution and site monitoring for a growing life sciences organization. This individual will independently manage monitoring activities while partnering with internal teams, sites, vendors, and external partners to ensure studies are executed efficiently and in compliance with applicable regulations.
Key Responsibilities
- Independently conduct site initiation, routine monitoring, and close-out activities.
- Oversee assigned sites, study timelines, deliverables, and issue resolution.
- Support study start-up and ongoing site/laboratory management activities.
- Maintain high-quality, inspection-ready clinical documentation and TMF records.
- Collaborate with cross-functional teams and external partners throughout study execution.
- Support vendor oversight, data/reporting activities, and study process improvements.
- Provide guidance and mentorship to less experienced clinical team members.
Qualifications
- Bachelor’s degree in life sciences or related field with 5+ years of relevant clinical research experience; advanced degree with comparable experience also considered.
- Strong independent monitoring experience across the clinical trial lifecycle.
- Solid understanding of GCP, ICH guidelines, clinical trial regulations, and essential study documentation.
- Experience managing multiple sites, priorities, and study timelines with limited oversight.
- Strong communication, problem-solving, and relationship-management skills.
- Experience with clinical trial systems and eTMF platforms.
- Oncology experience strongly preferred.
- Experience with diagnostic/device, CDx, laboratory, or precision medicine studies is a plus.
- Ability to travel approximately 10–20% as needed.
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