Sr. Clinical Research Associate
Structure Therapeutics
September 02, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. Ensures compliance with protocol and clinical trial objectives; implements and monitors clinical study activities in line with GCP, SOPs, and study protocols. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
Job Responsibilities
- Execute assigned clinical protocols to SOPs, ICH/GCP, and program goals.
- Support Study Lead across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendments; coordinate with medical writing.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure quality data and deliverables.
- Manage selected clinical sites; escalate issues; oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist with IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with CTA.
- Review/implement study design from an operations perspective; implement site tactics.
- Support CRO/Vendor RFP review and vendor selection activities.
- Develop/review study timelines and budgets.
- Contribute to key study documents (e.g., informed consent templates, site tools, FAQs, workflows) and maintain trial document development/distribution/tracking.
- Support clinical monitoring plan compliance; monitor as needed for training/QA.
- Update study plans and site-facing materials from initiation through execution.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast/monitor overall drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data and central record quality).
- Resolve protocol/study drug/safety/regulatory/legal questions or seek expert input; contribute to SOP review/Clinical Operations initiatives.
- Ensure Trial Master File (TMF) maintenance and periodic TMF QC/audits.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years of clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, SOP application, and medical terminology.
Required/Preferred Skills
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Attention to detail; ability to prioritize and meet critical deadlines.
- Proficiency in Microsoft Office; proficiency in Microsoft suite tools (e.g., Word, Excel).
Travel Required
- Up to 20%.
The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. Ensures compliance with protocol and clinical trial objectives; implements and monitors clinical study activities in line with GCP, SOPs, and study protocols. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
Job Responsibilities
- Execute assigned clinical protocols to SOPs, ICH/GCP, and program goals.
- Support Study Lead across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendments; coordinate with medical writing.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure quality data and deliverables.
- Manage selected clinical sites; escalate issues; oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist with IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with CTA.
- Review/implement study design from an operations perspective; implement site tactics.
- Support CRO/Vendor RFP review and vendor selection activities.
- Develop/review study timelines and budgets.
- Contribute to key study documents (e.g., informed consent templates, site tools, FAQs, workflows) and maintain trial document development/distribution/tracking.
- Support clinical monitoring plan compliance; monitor as needed for training/QA.
- Update study plans and site-facing materials from initiation through execution.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast/monitor overall drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data and central record quality).
- Resolve protocol/study drug/safety/regulatory/legal questions or seek expert input; contribute to SOP review/Clinical Operations initiatives.
- Ensure Trial Master File (TMF) maintenance and periodic TMF QC/audits.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years of clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, SOP application, and medical terminology.
Required/Preferred Skills
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Attention to detail; ability to prioritize and meet critical deadlines.
- Proficiency in Microsoft Office; proficiency in Microsoft suite tools (e.g., Word, Excel).
Travel Required
- Up to 20%.