Sr. Clinical Research Associate
Structure Therapeutics
10 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 clinical study or, with supervision, assumes significant management responsibilities on a large-scale study. Works with cross-functional teams, vendors, sites, and CROs to ensure protocol compliance and overall trial objectives. Implements and monitors clinical study activities to ensure adherence to GCP, SOPs, and study protocols.
Responsibilities:
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support Study Lead across study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track changes and initiate protocol amendments with medical writing.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement).
- Manage selected clinical sites; oversee CRO monitoring (review monitoring visit reports); support site contract/budget negotiations; assist IP shipment/reconciliation.
- Ensure meeting agenda/minutes accuracy with the CTA.
- Review/implement study design operationally; provide site-level tactics.
- Support CRO/vendor RFP reviews and vendor selection activities.
- Develop/review timelines and budgets; meet deliverables.
- Develop key documents (ICF templates, site monitoring tools, FAQs, processes/workflows).
- Develop, distribute, review, and track essential trial documents.
- Ensure compliance with the clinical monitoring plan; monitor for training/QA as needed.
- Support creation/updates of study plans and site-facing tools from initiation through execution.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast/monitor overall drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data quality, central records).
- Resolve or escalate protocol/study drug/safety/regulatory/legal questions as appropriate.
- Contribute to SOP review/Clinical Operations initiatives.
- Maintain and periodically QC/audit the Trial Master File (TMF).
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience preferred.
- Understanding of drug development, ICH/GCP, clinical trials process, SOP application, and medical terminology.
Skills/Requirements:
- Self-motivated; ability to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and communication skills.
- Strong attention to detail; prioritize to meet deadlines.
- Proficiency with Microsoft Office; Microsoft Word/Excel.
Travel:
- Up to 20%.
Benefits:
- Medical, dental, vision insurance; 401(k) match; unlimited PTO; paid holidays including winter shutdown.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Compensation (base pay range):
- $135,000–$150,000 (exact depends on factors including geography, qualifications, skills, experience).
The Sr. Clinical Research Associate (Sr. CRA) independently manages all clinical aspects of a small to medium-sized clinical study or, with supervision, assumes significant management responsibilities on a large-scale study. Works with cross-functional teams, vendors, sites, and CROs to ensure protocol compliance and overall trial objectives. Implements and monitors clinical study activities to ensure adherence to GCP, SOPs, and study protocols.
Responsibilities:
- Execute assigned clinical protocols per SOPs, ICH/GCP, and program goals.
- Support Study Lead across study start-up, enrollment, maintenance, and closeout.
- Participate in protocol development; track changes and initiate protocol amendments with medical writing.
- Oversee study management and vendors (e.g., IRT, eCOA, cardiac safety, patient reimbursement).
- Manage selected clinical sites; oversee CRO monitoring (review monitoring visit reports); support site contract/budget negotiations; assist IP shipment/reconciliation.
- Ensure meeting agenda/minutes accuracy with the CTA.
- Review/implement study design operationally; provide site-level tactics.
- Support CRO/vendor RFP reviews and vendor selection activities.
- Develop/review timelines and budgets; meet deliverables.
- Develop key documents (ICF templates, site monitoring tools, FAQs, processes/workflows).
- Develop, distribute, review, and track essential trial documents.
- Ensure compliance with the clinical monitoring plan; monitor for training/QA as needed.
- Support creation/updates of study plans and site-facing tools from initiation through execution.
- Contribute to CRF design (content, UAT, layout, edit checks).
- Forecast/monitor overall drug supply.
- Support study-wide activities (vendors, sample handling, investigator payments, data quality, central records).
- Resolve or escalate protocol/study drug/safety/regulatory/legal questions as appropriate.
- Contribute to SOP review/Clinical Operations initiatives.
- Maintain and periodically QC/audit the Trial Master File (TMF).
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- Minimum 4 years clinical trial management experience (Sponsor, CRA/field monitor, or CRO); global experience preferred.
- Understanding of drug development, ICH/GCP, clinical trials process, SOP application, and medical terminology.
Skills/Requirements:
- Self-motivated; ability to motivate others.
- Strong interpersonal, problem-solving, organizational, planning, and communication skills.
- Strong attention to detail; prioritize to meet deadlines.
- Proficiency with Microsoft Office; Microsoft Word/Excel.
Travel:
- Up to 20%.
Benefits:
- Medical, dental, vision insurance; 401(k) match; unlimited PTO; paid holidays including winter shutdown.
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Compensation (base pay range):
- $135,000–$150,000 (exact depends on factors including geography, qualifications, skills, experience).