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 clinical study or, with supervision, significant management responsibilities on a large-scale study. Works with cross-functional teams, vendors, sites, and CROs to ensure compliance with protocol and clinical trial objectives. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
Responsibilities
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support Study Lead for start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendment tracking/initiations.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure quality data and deliverables.
- Manage selected clinical sites; escalate issues and oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist with Investigational Product shipment/reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Review/implement study design operationally and implement site-level tactics.
- Support CRO/vendor RFP review, bid defenses, and proposal feedback.
- Develop/review study timelines and budgets.
- Contribute to key study documents and trial documents development, distribution, review, and tracking.
- Ensure compliance with clinical monitoring plan; monitor for training/QA as needed.
- Support study plan/Informed Consent Form updates, feasibility questionnaires, and initiation through execution materials.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast/monitor drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data/central records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions or seek expert input.
- Contribute to SOP review/Clinical Operations initiatives.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications
- Bachelor’s degree in relevant scientific discipline.
- Minimum 4 years of clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, clinical trial process, SOP application, and medical terminology.
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning; excellent verbal and written communication.
- Strong attention to detail; prioritization to meet deadlines.
- Strong Microsoft Office proficiency (including Word/Excel).
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Travel
- Up to 20%.
- The Sr. Clinical Research Associate (Sr. CRA) independently manages all clinical aspects of a small to medium-sized clinical study or, with supervision, significant management responsibilities on a large-scale study. Works with cross-functional teams, vendors, sites, and CROs to ensure compliance with protocol and clinical trial objectives. Reports to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
Responsibilities
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support Study Lead for start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendment tracking/initiations.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure quality data and deliverables.
- Manage selected clinical sites; escalate issues and oversee CRO monitoring; review monitoring reports; support site contract/budget negotiations; assist with Investigational Product shipment/reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Review/implement study design operationally and implement site-level tactics.
- Support CRO/vendor RFP review, bid defenses, and proposal feedback.
- Develop/review study timelines and budgets.
- Contribute to key study documents and trial documents development, distribution, review, and tracking.
- Ensure compliance with clinical monitoring plan; monitor for training/QA as needed.
- Support study plan/Informed Consent Form updates, feasibility questionnaires, and initiation through execution materials.
- Support CRF design (content, UAT, layout, edit checks).
- Forecast/monitor drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data/central records quality).
- Resolve protocol/study drug/safety/regulatory/legal questions or seek expert input.
- Contribute to SOP review/Clinical Operations initiatives.
- Maintain Trial Master File (TMF) and support TMF QC/audits.
Qualifications
- Bachelor’s degree in relevant scientific discipline.
- Minimum 4 years of clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience a plus.
- Understanding of drug development process, ICH/GCP, clinical trial process, SOP application, and medical terminology.
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning; excellent verbal and written communication.
- Strong attention to detail; prioritization to meet deadlines.
- Strong Microsoft Office proficiency (including Word/Excel).
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Travel
- Up to 20%.