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 Assistant (Sr. CRA) independently manages clinical aspects of a small to medium-sized clinical study, or with supervision assumes significant management responsibilities on a large-scale study. Ensures compliance with protocol and overall clinical trial objectives; implements and monitors clinical study activities in accordance with GCPs, SOPs, and study protocols. 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 Lead across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track changes and initiate 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 clinical sites; oversee CRO monitoring activities; review monitoring reports; assist with site contract/budget negotiations; support IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with CTA.
- Implement site-level tactics; may support CRO/vendor RFP review and vendor selection.
- Develop/review study timelines and budgets.
- Contribute to critical documents (ICF templates, site monitoring tools, FAQs, processes/workflows).
- Develop/distribute/review/track trial documents; ensure timelines/deliverables within budget.
- Ensure compliance with clinical monitoring plan; monitor for training/QA as needed.
- Support development of study plans and site-facing materials from initiation to execution.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply; support study-wide activities (vendors, sample handling, investigator payments, data/records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions; 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, ICH/GCP, clinical trials process, SOP application, and medical terminology.
Skills
- Self-motivated; strong interpersonal/problem-solving/organizational/planning skills.
- Excellent verbal and written communication.
- Strong attention to detail; prioritize to meet deadlines.
- Proficient with Microsoft Office and Microsoft suite (e.g., Word, Excel).
Other
- Travel required: up to 20%.
The Sr. Clinical Research Assistant (Sr. CRA) independently manages clinical aspects of a small to medium-sized clinical study, or with supervision assumes significant management responsibilities on a large-scale study. Ensures compliance with protocol and overall clinical trial objectives; implements and monitors clinical study activities in accordance with GCPs, SOPs, and study protocols. 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 Lead across start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track changes and initiate 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 clinical sites; oversee CRO monitoring activities; review monitoring reports; assist with site contract/budget negotiations; support IP shipment/reconciliation.
- Coordinate meeting agendas/minutes with CTA.
- Implement site-level tactics; may support CRO/vendor RFP review and vendor selection.
- Develop/review study timelines and budgets.
- Contribute to critical documents (ICF templates, site monitoring tools, FAQs, processes/workflows).
- Develop/distribute/review/track trial documents; ensure timelines/deliverables within budget.
- Ensure compliance with clinical monitoring plan; monitor for training/QA as needed.
- Support development of study plans and site-facing materials from initiation to execution.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply; support study-wide activities (vendors, sample handling, investigator payments, data/records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions; 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, ICH/GCP, clinical trials process, SOP application, and medical terminology.
Skills
- Self-motivated; strong interpersonal/problem-solving/organizational/planning skills.
- Excellent verbal and written communication.
- Strong attention to detail; prioritize to meet deadlines.
- Proficient with Microsoft Office and Microsoft suite (e.g., Word, Excel).
Other
- Travel required: up to 20%.