Sr. Clinical Research Associate
Structure Therapeutics
14 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
Sr. Clinical Research Associate (Sr. CRA) independently manages clinical aspects of a small to medium-sized study or, with supervision, major responsibilities on large-scale studies. Ensures compliance with protocol, GCP, and SOPs. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred (remote considered).
Job Responsibilities:
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support study start-up, enrollment, maintenance, and closeout with the Study Lead.
- Participate in protocol development; track changes and support protocol amendments.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure data quality and deliverables.
- Manage selected sites; oversee CRO monitoring and review monitoring reports; support site contract/budget negotiations; assist with IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Support operations review/implementation of study design and site-level tactics.
- Support CRO/vendor RFP review, bids, and proposal comments.
- Develop/review study timelines and budgets; meet deliverables within budget.
- Contribute to essential trial documents (informed consent templates, site monitoring tools, FAQs, processes/workflows) and CRF design (content, UAT, layout, edit checks).
- Maintain TMF, support TMF QC/audits, and ensure compliance with the clinical monitoring plan.
- Forecast/monitor drug supply; support sample handling, investigator payments, data quality, and central records.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 4+ years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development, ICH/GCP, clinical trials process, SOP application, and medical terminology.
- Self-motivated; strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Detail-oriented; prioritizes to meet critical deadlines.
- Strong Microsoft Office skills (Word/Excel, etc.).
Travel Required: Up to 20%.
Benefits (as stated): medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Sr. Clinical Research Associate (Sr. CRA) independently manages clinical aspects of a small to medium-sized study or, with supervision, major responsibilities on large-scale studies. Ensures compliance with protocol, GCP, and SOPs. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred (remote considered).
Job Responsibilities:
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support study start-up, enrollment, maintenance, and closeout with the Study Lead.
- Participate in protocol development; track changes and support protocol amendments.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure data quality and deliverables.
- Manage selected sites; oversee CRO monitoring and review monitoring reports; support site contract/budget negotiations; assist with IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Support operations review/implementation of study design and site-level tactics.
- Support CRO/vendor RFP review, bids, and proposal comments.
- Develop/review study timelines and budgets; meet deliverables within budget.
- Contribute to essential trial documents (informed consent templates, site monitoring tools, FAQs, processes/workflows) and CRF design (content, UAT, layout, edit checks).
- Maintain TMF, support TMF QC/audits, and ensure compliance with the clinical monitoring plan.
- Forecast/monitor drug supply; support sample handling, investigator payments, data quality, and central records.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 4+ years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development, ICH/GCP, clinical trials process, SOP application, and medical terminology.
- Self-motivated; strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Detail-oriented; prioritizes to meet critical deadlines.
- Strong Microsoft Office skills (Word/Excel, etc.).
Travel Required: Up to 20%.
Benefits (as stated): medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.