Sr. Clinical Research Associate/Clinical Trial Manager
BridgeBio
August 20, 2026
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
Position Summary & Responsibilities
- Collaborate with Clinical Operations to support timely conduct of clinical studies per protocol, GCP, SOPs, and regulations; perform quality study oversight (monitoring communications and reviewing monitoring trip reports).
- Support clinical studies from planning/start-up through execution, maintenance, and close-out.
- Lead operational management for assigned regions/sites: monitor performance metrics, identify/mitigate risks, drive escalations/action-item closure, represent regional performance.
- Serve as primary sponsor contact for assigned investigators/sites; build relationships and resolve issues.
- Lead vendor management for CRO and key vendors (IRT, imaging, central/specialty labs): set expectations, ensure deliverables, maintain performance measures, escalate and drive corrective actions.
- Provide oversight of CRO monitors: review documentation, evaluate monitor/site performance, conduct oversight/co-monitoring visits as needed, identify systemic risks.
- Maintain/analyze study tracking tools and operational metrics (start-up, screening, enrollment, visits, data entry, queries, monitoring).
- Contribute to study documents (ICFs, CRFs, monitoring plans, templates, protocols, investigator brochures, regulatory materials).
- Ensure Trial Master File is complete/current/accurate/inspection-ready.
- Assist with Investigational Product (IP) shipment/reconciliation as needed.
- Apply ICH E6(R3) GCP principles and escalate study execution concerns.
- Oversee operational study needs (e.g., clinical supplies); participate in site budget/contract review; support investigator meetings.
- Promote collaborative, respectful, quality-focused environment; additional activities as assigned. Travel up to 20%.
Education/Experience
- Bachelor’s degree or equivalent (e.g., RN/PA, BSN). Minimum 4–6 years clinical study experience.
Required Skills/Competencies
- Global study experience in fast-paced environments.
- Experience working with CROs and vendors.
- Excellent communication; ability to achieve milestones in teams.
- Respectful collaboration in a remote environment.
Preferred Qualifications
- Biotechnology/pharmaceutical sponsor organization experience.
- Monitoring CRA experience (initiation, interim monitoring, close-out visits).
- Trial Master File oversight/maintenance experience.
- Working knowledge of ICH E6(R3) and risk-based quality management.
- Proficiency with Microsoft Office (Excel/Word/PowerPoint) and SmartSheet.
Benefits (explicitly listed)
- 401(k) match, ESPP, pre-tax commuter benefits, referral bonus, subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums (incl. dependents), HSA contributions, FSA, fertility/family benefits, mental health support, hybrid flexibility, paid time off/holidays, paid medical and parental leave.
- Collaborate with Clinical Operations to support timely conduct of clinical studies per protocol, GCP, SOPs, and regulations; perform quality study oversight (monitoring communications and reviewing monitoring trip reports).
- Support clinical studies from planning/start-up through execution, maintenance, and close-out.
- Lead operational management for assigned regions/sites: monitor performance metrics, identify/mitigate risks, drive escalations/action-item closure, represent regional performance.
- Serve as primary sponsor contact for assigned investigators/sites; build relationships and resolve issues.
- Lead vendor management for CRO and key vendors (IRT, imaging, central/specialty labs): set expectations, ensure deliverables, maintain performance measures, escalate and drive corrective actions.
- Provide oversight of CRO monitors: review documentation, evaluate monitor/site performance, conduct oversight/co-monitoring visits as needed, identify systemic risks.
- Maintain/analyze study tracking tools and operational metrics (start-up, screening, enrollment, visits, data entry, queries, monitoring).
- Contribute to study documents (ICFs, CRFs, monitoring plans, templates, protocols, investigator brochures, regulatory materials).
- Ensure Trial Master File is complete/current/accurate/inspection-ready.
- Assist with Investigational Product (IP) shipment/reconciliation as needed.
- Apply ICH E6(R3) GCP principles and escalate study execution concerns.
- Oversee operational study needs (e.g., clinical supplies); participate in site budget/contract review; support investigator meetings.
- Promote collaborative, respectful, quality-focused environment; additional activities as assigned. Travel up to 20%.
Education/Experience
- Bachelor’s degree or equivalent (e.g., RN/PA, BSN). Minimum 4–6 years clinical study experience.
Required Skills/Competencies
- Global study experience in fast-paced environments.
- Experience working with CROs and vendors.
- Excellent communication; ability to achieve milestones in teams.
- Respectful collaboration in a remote environment.
Preferred Qualifications
- Biotechnology/pharmaceutical sponsor organization experience.
- Monitoring CRA experience (initiation, interim monitoring, close-out visits).
- Trial Master File oversight/maintenance experience.
- Working knowledge of ICH E6(R3) and risk-based quality management.
- Proficiency with Microsoft Office (Excel/Word/PowerPoint) and SmartSheet.
Benefits (explicitly listed)
- 401(k) match, ESPP, pre-tax commuter benefits, referral bonus, subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums (incl. dependents), HSA contributions, FSA, fertility/family benefits, mental health support, hybrid flexibility, paid time off/holidays, paid medical and parental leave.