Clinical Trial Operations Specialist

Lakefront Biotherapeutics; San Francisco (CA); On-site; USD 110,000 - 130,000; Full time

Job summary

Lakefront Biotherapeutics is seeking a Clinical Trial Associate to support execution of multiple clinical studies and partner across cross-functional teams. The CTA will focus on study start-up, sponsor access management, vendor data reconciliation, QC, and TMF oversight, ensuring high-quality deliverables.

The ideal candidate has 2+ years of CTA experience, TMF and regulatory docs expertise, and strong communication skills to collaborate with CROs, labs, and external partners.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field.
• 2+ years of CTA experience in biotech/pharma/CRO environments.
• Experience supporting clinical study operations, including vendor oversight, data reconciliation, and QC.
• Strong TMF maintenance and study documentation management.
• Proven ability to manage study progress/oversight tools.
• Excellent organizational, problem-solving, and communication skills across cross-functional teams and external partners.
• Proficient with Microsoft Office Suite and trial tracking systems.

Responsibilities

• Support clinical studies in partnership with CROs and lab vendors.
• Review and reconcile vendor data listings; perform QC checks for accuracy and compliance.
• Monitor CRO/lab deliverables against timelines and quality standards.
• Maintain study trackers, sponsor access management, oversight logs, and regulatory files ( TMF, site/vendor contacts, approvals ).
• Ensure completeness and compliance of the TMF through ongoing QC review.
• Assist with regulatory document review (EDPs, ICFs, lab certifications, IRB/IEC submissions).
• Support study start-up, site/vendor onboarding, and supply management.
• Contribute to study materials and drive process improvement; strengthen vendor oversight.

Skills

CTA experience

Vendor oversight

Data reconciliation

TMF maintenance

Regulatory document review

Communication

Education

Bachelor’s degree in life sciences, healthcare, or related field

Tools

Microsoft Office Suite

Clinical trial tracking systems

Job description

Lakefront Biotherapeutics is seeking a Clinical Trial Associate to support execution of multiple clinical studies and partner across cross-functional teams. The CTA will focus on study start-up, sponsor access management, vendor data reconciliation, QC, and TMF oversight, ensuring high-quality deliverables.

The ideal candidate has 2+ years of CTA experience, TMF and regulatory docs expertise, and strong communication skills to collaborate with CROs, labs, and external partners.