Sr. Clinical Research Associate
Structure Therapeutics
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
The Sr. Clinical Research Associate (Sr. CRA) independently manages all clinical aspects of a small to medium-sized study or, with supervision, assumes significant management responsibilities on a large-scale study. Ensures compliance with protocol and clinical trial objectives and implements/monitors clinical 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 across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track and initiate amendments as needed.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure high-quality data and deliverables.
- Manage selected clinical sites; oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist IP shipment/reconciliation.
- Support creation, tracking, and accuracy of agendas/minutes with CTA.
- Implement study design tactics at site level; support CRO/vendor RFP review and vendor selection.
- Develop/review study timelines and budgets; meet deliverables within budget.
- Develop trial documents (e.g., informed consent templates, site monitoring tools, FAQs, workflows); maintain essential trial documents.
- Ensure compliance with the clinical monitoring plan; monitor as needed for training/QA.
- Create/update study plans, consent forms, feasibility questionnaires, and site initiation materials/tools.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast/monitor drug supply; support study-wide activities (vendors, sample handling, investigator payments, data quality, central records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions and contribute to SOP review.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 4+ years of 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.
Skills/Experience
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Attention to detail; prioritize to meet critical deadlines.
- Proficient in Microsoft Office and Microsoft suite (Word, Excel, etc.).
Travel Required: Up to 20%
The Sr. Clinical Research Associate (Sr. CRA) independently manages all clinical aspects of a small to medium-sized study or, with supervision, assumes significant management responsibilities on a large-scale study. Ensures compliance with protocol and clinical trial objectives and implements/monitors clinical 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 across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track and initiate amendments as needed.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure high-quality data and deliverables.
- Manage selected clinical sites; oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist IP shipment/reconciliation.
- Support creation, tracking, and accuracy of agendas/minutes with CTA.
- Implement study design tactics at site level; support CRO/vendor RFP review and vendor selection.
- Develop/review study timelines and budgets; meet deliverables within budget.
- Develop trial documents (e.g., informed consent templates, site monitoring tools, FAQs, workflows); maintain essential trial documents.
- Ensure compliance with the clinical monitoring plan; monitor as needed for training/QA.
- Create/update study plans, consent forms, feasibility questionnaires, and site initiation materials/tools.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast/monitor drug supply; support study-wide activities (vendors, sample handling, investigator payments, data quality, central records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions and contribute to SOP review.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 4+ years of 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.
Skills/Experience
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Attention to detail; prioritize to meet critical deadlines.
- Proficient in Microsoft Office and Microsoft suite (Word, Excel, etc.).
Travel Required: Up to 20%