Sr. Clinical Research Associate
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position: Sr. Clinical Research Associate (Sr. CRA)
Job Responsibilities:
- Independently manage clinical aspects of small to mid-sized studies; with supervision, support large-scale study management.
- Ensure quality execution of clinical protocols per SOPs, ICH/GCP, and program goals.
- Support study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendment tracking; coordinate amendments with medical writing as needed.
- Oversee study/vendor management (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure high-quality data and timely deliverables.
- Manage selected clinical sites; oversee CRO monitoring (review monitoring visit reports, support site contract/budget negotiations); assist with Investigational Product shipment and reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Implement study design operations tactics at the site level.
- Support Study Lead in CRO/vendor RFP review, bid defenses, and vendor proposal review.
- Support development/review of timelines and budgets.
- Contribute to critical documents (informed consent templates, site tools/monitoring tools, FAQs, workflows) and essential trial document distribution/tracking.
- Support clinical monitoring plan compliance; monitor as needed for training/QA.
- Support documents/materials from initiation through execution (e.g., feasibility/qualification materials, initiation presentations).
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply.
- Support other study-wide activities (external vendors, sample handling, investigator payments, data quality, central records quality).
- Ensure TMF maintenance with periodic 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 process, ICH/GCP, SOP application, and medical terminology.
Skills:
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Strong attention to detail; ability to prioritize to meet deadlines.
- Proficient in Microsoft Office (e.g., Word, Excel).
Travel Required: Up to 20%.
Benefits (as stated): Medical/dental/vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Compensation (as stated): Anticipated base pay range $135,000–$150,000.
Job Responsibilities:
- Independently manage clinical aspects of small to mid-sized studies; with supervision, support large-scale study management.
- Ensure quality execution of clinical protocols per SOPs, ICH/GCP, and program goals.
- Support study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development and protocol amendment tracking; coordinate amendments with medical writing as needed.
- Oversee study/vendor management (e.g., IRT, eCOA, cardiac safety, patient reimbursement) to ensure high-quality data and timely deliverables.
- Manage selected clinical sites; oversee CRO monitoring (review monitoring visit reports, support site contract/budget negotiations); assist with Investigational Product shipment and reconciliation.
- Coordinate meeting agendas/minutes with the CTA.
- Implement study design operations tactics at the site level.
- Support Study Lead in CRO/vendor RFP review, bid defenses, and vendor proposal review.
- Support development/review of timelines and budgets.
- Contribute to critical documents (informed consent templates, site tools/monitoring tools, FAQs, workflows) and essential trial document distribution/tracking.
- Support clinical monitoring plan compliance; monitor as needed for training/QA.
- Support documents/materials from initiation through execution (e.g., feasibility/qualification materials, initiation presentations).
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast and monitor drug supply.
- Support other study-wide activities (external vendors, sample handling, investigator payments, data quality, central records quality).
- Ensure TMF maintenance with periodic 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 process, ICH/GCP, SOP application, and medical terminology.
Skills:
- Self-motivated; able to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and verbal/written communication skills.
- Strong attention to detail; ability to prioritize to meet deadlines.
- Proficient in Microsoft Office (e.g., Word, Excel).
Travel Required: Up to 20%.
Benefits (as stated): Medical/dental/vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Compensation (as stated): Anticipated base pay range $135,000–$150,000.