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 escalate material risks with recommended actions.
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 escalate 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 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. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
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.
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