Senior Biospecimen Operations CRA

Structure Therapeutics, Inc.; South San Francisco, Northern (CA, KY); Hybrid; USD 135,000 - 145,000; Full time

Benefits offered by this job

Annual bonus

New hire equity

Equity

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics, Inc. seeks a Senior Clinical Research Associate in Biospecimen Management to join our Clinical Operations team.

This role independently manages laboratory and biospecimen workflows for assigned clinical studies, coordinating with vendors and internal teams to ensure sample integrity and timely data. You will mentor junior staff, oversee risk and issue management, and contribute to SOPs while ensuring compliance with ICH GCP and regulatory requirements across global

Qualifications

• Bachelor's degree or equivalent in a scientific or healthcare discipline.
• At least 4 years of industry experience in clinical research or biospecimen management.
• At least 2 years coordinating study-level laboratory vendors or biospecimen operations.
• Experience overseeing sample logistics in multicenter trials.
• Experience supporting global studies preferred.

Responsibilities

• Lead biospecimen and laboratory operations for assigned studies from start-up through closeout.
• Translate protocols into operational timelines and vendor requirements.
• Oversee laboratory manuals, sample collection guidance, and kit specifications.
• Manage study-level risk and issue plans and escalate material risks.
• Provide day-to-day oversight of central and specialty laboratories and vendors.
• Monitor vendor performance and lead investigations into issues.
• Ensure compliance with ICH GCP and regulatory requirements.
• Mentor junior staff (not direct management).

Skills

Strong knowledge of clinical trial and

Planning & risk assessment

Written and verbal communication

Influence cross-functional teams

Mentor Clinical Research Associates

Microsoft Office

Education

Bachelor's degree or equivalent experience

Tools

EDC

CTMS

eTMF

Microsoft Office

Job description

Structure Therapeutics, Inc. seeks a Senior Clinical Research Associate in Biospecimen Management to join our Clinical Operations team.

This role independently manages laboratory and biospecimen workflows for assigned clinical studies, coordinating with vendors and internal teams to ensure sample integrity and timely data. You will mentor junior staff, oversee risk and issue management, and contribute to SOPs while ensuring compliance with ICH GCP and regulatory requirements across global