Senior Clinical Research Associate

BioPhase Inc.; San Francisco (CA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

BioPhase Inc. in San Francisco seeks an experienced Senior Clinical Research Associate (CRA) to support trial execution and site monitoring.

You will independently manage monitoring activities and collaborate with internal teams, sites, vendors, and external partners to ensure studies are conducted efficiently and in compliance with regulations. The role requires a Bachelor’s degree in life sciences with 5+ years of clinical research experience, strong GCP/ICH knowledge, multi-site oversight,

Qualifications

• Bachelor’s degree in life sciences or related field; 5+ years of clinical research experience.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Experience monitoring multiple sites with limited supervision.

Responsabilités

• 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 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 process improvements.
• Provide guidance and mentorship to less experienced clinical team members.

Connaissances

Independent monitoring

GCP/ICH knowledge

Multi-site oversight

Communication skills

Travel readiness

Formation

Bachelor’s degree in life sciences or related field

Advanced degree or equivalent experience considered

Description du poste

• 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.