Sr. Clinical Research Associate
Structure Therapeutics
August 22, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
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. Works with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and clinical trial objectives. Implements and monitors clinical study activities to assure adherence to 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 per SOPs, ICH/GCP, and program goals.
- Support Study Lead for study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendments (with medical writing).
- 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 (monitoring reports review, site contract/budget negotiations); assist with IP shipment/reconciliation.
- Coordinate meeting agendas and minutes with the CTA.
- Review/implement study design operationally and implement site tactics.
- Support CRO/Vendor RFP review, bid defenses, and vendor proposal comments.
- Develop/review timelines and budgets to meet deliverables.
- Create/maintain key study documents (informed consent templates, site tools, FAQs/workflows).
- Develop/distribute/review essential trial documents; ensure timelines within budget.
- Ensure compliance with the clinical monitoring plan; monitor for training/QA as needed.
- Support study planning materials from initiation through execution.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data/central records quality).
- Resolve protocol/study drug/safety/regulatory/legal issues or seek expert input; contribute to SOP review and clinical operations initiatives.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, clinical trials, SOP application, and medical terminology.
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Strong attention to detail; prioritization for critical deadlines.
- Proficient in Microsoft Office; ability to use computer tools; proficiency in Microsoft Word/Excel.
Skills/Additional:
- Professionalism/integrity, teamwork, cooperation, flexibility.
Travel Required:
- Up to 20%.
Benefits (explicitly stated):
- Base pay range: $135,000–$145,000.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown.
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. Works with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and clinical trial objectives. Implements and monitors clinical study activities to assure adherence to 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 per SOPs, ICH/GCP, and program goals.
- Support Study Lead for study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendments (with medical writing).
- 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 (monitoring reports review, site contract/budget negotiations); assist with IP shipment/reconciliation.
- Coordinate meeting agendas and minutes with the CTA.
- Review/implement study design operationally and implement site tactics.
- Support CRO/Vendor RFP review, bid defenses, and vendor proposal comments.
- Develop/review timelines and budgets to meet deliverables.
- Create/maintain key study documents (informed consent templates, site tools, FAQs/workflows).
- Develop/distribute/review essential trial documents; ensure timelines within budget.
- Ensure compliance with the clinical monitoring plan; monitor for training/QA as needed.
- Support study planning materials from initiation through execution.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data/central records quality).
- Resolve protocol/study drug/safety/regulatory/legal issues or seek expert input; contribute to SOP review and clinical operations initiatives.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, clinical trials, SOP application, and medical terminology.
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Strong attention to detail; prioritization for critical deadlines.
- Proficient in Microsoft Office; ability to use computer tools; proficiency in Microsoft Word/Excel.
Skills/Additional:
- Professionalism/integrity, teamwork, cooperation, flexibility.
Travel Required:
- Up to 20%.
Benefits (explicitly stated):
- Base pay range: $135,000–$145,000.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, vision; 401k match; unlimited PTO; paid holidays including winter shutdown.