Sr. Clinical Research Associate
Structure Therapeutics
15 days 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%