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 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%.