Sr. Clinical Research Associate, Biospecimen Management

Structure Therapeutics; South San Francisco (CA); On-site; USD 135,000 - 145,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Unlimited PTO

Winter Shutdown

Job summary

Structure Therapeutics seeks a Senior Clinical Research Associate in Biospecimen Management to join our Clinical Operations team. You will independently manage laboratory and biospecimen operations for assigned studies, translating sample analysis requirements into executable plans, and overseeing vendors.

You will mentor junior staff, resolve study-level issues, ensure compliance with ICH/GCP, and contribute to SOPs and process improvements. Travel up to 20% may be required.

Qualifications

• Knowledge of clinical trial processes and biospecimen lifecycle.
• Experience coordinating lab vendors or biospecimen operations in drug development.
• Strong written and verbal communication; ability to mentor teammates.

Responsibilities

• Lead biospecimen and laboratory operations for assigned studies from start-up to closeout.
• Translate protocols into operational timelines and vendor requirements.
• Lead development of laboratory manuals and sample collection guidance.
• Ensure alignment among protocols, documents, data requirements, and timelines.
• Maintain study-level risk plans and escalate contractual or budget issues when needed.

Skills

Clinical trial processes

Vendor management

Communication skills

Cross-functional influence

Education

Bachelor's degree or equivalent

Tools

EDC

CTMS

eTMF

MS Office

Job description

About Us

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines advances in visualization of molecular interactions, computational chemistry, and data integration to design orally available small-molecule medicines intended to overcome limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering in February 2023. With offices in California and Shanghai, Structure Therapeutics operates at the center of life sciences innovation in the United States and China.

Position Summary

Structure Therapeutics is seeking a Senior Clinical Research Associate in Biospecimen Management to join our Clinical Operations team. Reporting to the Senior Manager, Biospecimen Management, this role independently manages laboratory and biospecimen operations for assigned clinical studies and may support multiple studies within a program. The Senior Clinical Research Associate translates sample analysis requirements into executable plans, oversees laboratory vendors, and maintains control of sample flow, reconciliation, analysis status, and storage. This role leads resolution of study-level issues, keeps stakeholders informed of risks and decisions, and mentors less-experienced team members while escalating program-level, contractual, or strategic matters.

Job Responsibilities

Study and Laboratory Operations

• Lead biospecimen and laboratory operations for assigned studies from study start-up through closeout.
• Translate protocols and sample analysis plans into operational timelines, deliverables, and clear vendor requirements in collaboration with Clinical Development and Translational Sciences.
• Lead development and review of laboratory manuals, sample collection guidance, kit specifications, and related operational documents.
• Confirm alignment among protocols, laboratory documents, data requirements, vendor capabilities, and overall study timelines.
• Maintain study-level risk and issue plans, implement mitigations within the role's authority, and escalat matter.

Laboratory Vendor Oversight

• Provide day-to-day oversight of central laboratories, specialty laboratories, bioanalytical vendors, biomarker vendors, and short/long term storage partners for assigned studies.
• Lead routine governance meetings and hold vendors accountable for deliverables, quality expectations, timelines, and documented actions.
• Monitor vendor performance indicators and trends; lead investigation, escalation, and resolution of performance issues.
• Review scopes of work, budgets, invoices, change orders, and assumptions for operational accuracy and escalat contractual or budget decisions to the biospecimen lead.
• Contribute subject-matter input to requests for information, requests for proposal, proposal evaluations, and bid-defense meetings.

Sample Lifecycle and Data Oversight

• Oversee collection, processing, shipment, receipt, tracking, reconciliation, analysis, and storage of samples across assigned studies.
• Establish and maintain study-level sample tracking and reconciliation plans with laboratories, Data Management, and study teams.
• Analyze sample metrics and discrepancy trends, lead root-cause assessment, and drive corrective actions to closure.
• Manage risks related to sample integrity, stability, consent restrictions, chain of custody, and shipment conditions in partnership with relevant functions.
• Ensure biospecimen records, decisions, and vendor deliverables are complete, accurate, and inspection-ready.

Compliance Quality and Team Contribution

• Ensure assigned laboratory and biospecimen activities comply with protocols, ICH Good Clinical Practice, applicable regulatory requirements, and company standard operating procedures.
• Lead preparation of biospecimen documentation for audits and inspections and coordinate timely responses to observations or follow-up requests.
• Contribute to standard operating procedures, templates, metrics, and process improvements for biospecimen management.
• Provide clear study updates and recommendations to Clinical Operations, Clinical Development, Translational Sciences, Data Management, Quality, and other stakeholders.
• Mentor Clinical Research Associates and support onboarding and knowledge sharing; this role does not have direct people-management responsibility.

Qualifications

Education

• Bachelor's degree or equivalent experience; a scientific or healthcare discipline is preferred.

Experience

• At least 4 years of industry experience in clinical research, laboratory operations, biospecimen management, or a related function with increasing responsibility.
• At least 2 years of experience independently coordinating study-level laboratory vendors or biospecimen operations in clinical drug development.
• Demonstrated experience with central laboratories, specialty laboratories, biomarker vendors, or bioanalytical partners in multicenter trials.
• Experience overseeing sample logistics, reconciliation, analysis status, and lifecycle management.
• Experience reviewing vendor scopes, budgets, invoices, or change orders is preferred.
• Experience supporting global studies in the United States, Europe, or Asia-Pacific is preferred.

Core Competencies Knowledge and Skills

• Strong knowledge of clinical trial processes, laboratory operations, and biospecimen lifecycle management.
• Knowledge of FDA, European Union, and ICH Good Clinical Practice requirements related to biospecimen handling.
• Ability to independently oversee vendors, interpret performance information, and drive issues to resolution.
• Strong planning, risk assessment, decision-making, and written and verbal communication skills.
• Ability to influence cross-functional teams without direct authority and mentor less-experienced colleagues.
• Experience with Microsoft Office and clinical systems such as EDC, CTMS, and eTMF.

Travel

Up to 20% travel may be required.

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $135,000-$145,000.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.