Senior Clinical Research Associate
Edgewise Therapeutics
3 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Key Responsibilities:
- Lead site start-up activities (oversight of CRO start-up, essential document package review, site initiation materials, vendor training; participate in remote/on-site initiation visits) and contribute to feasibility.
- Collaborate with the contracts team to review and negotiate site/vendor budgets and contracts.
- Develop and review study/patient/site-facing documents (protocols, ICFs, study plans).
- Oversee Edgewise contract CRA and/or CRO monitoring (visit schedules, monitoring visit reviews, monitoring plan review); may include co-monitoring, compliance with protocol/regulatory requirements, monitoring training for CRO personnel, attending monitoring meetings, and assigned site monitoring.
- Review/oversee site KPIs, protocol deviations, and metrics; escalate risks/non-compliance and review SCAPAs/CAPAs and site audits with Quality Assurance.
- Support clinical study lead tracking regulatory submissions/approvals, recruitment/enrollment, and other assigned tasks.
- Proactively review EDC, generate queries, identify risks/decisions, implement mitigation, and solve operational challenges.
- Draft/adopt SOPs and ensure studies are “inspection ready”; may support regulatory inspections.
- Oversee assigned vendors; collaborate with internal teams for seamless trial execution and regular study updates.
- May review site/vendor invoicing and financial management; support TMF activities.
- Support onboarding and mentoring.
Required Education/Experience/Skills:
- 4+ years clinical operations experience; BS/BA (Life Sciences).
- 4+ years independent on-site monitoring (all visit types; incl. remote); 3+ years cardiac study experience in pharma sponsor environment preferred.
- Strong attention to detail; verbal/written/interpersonal/presentation skills.
- Familiarity with medical/scientific terminology.
- MS Office (incl. PPT); SmartSheet desirable.
- Knowledge of FDA/ICH/GCP.
- Ability to participate in strategic initiatives under general supervision.
- Highly productive, accountable, team-oriented.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off.
Application Instructions:
- Ongoing applications (no deadline).
- Lead site start-up activities (oversight of CRO start-up, essential document package review, site initiation materials, vendor training; participate in remote/on-site initiation visits) and contribute to feasibility.
- Collaborate with the contracts team to review and negotiate site/vendor budgets and contracts.
- Develop and review study/patient/site-facing documents (protocols, ICFs, study plans).
- Oversee Edgewise contract CRA and/or CRO monitoring (visit schedules, monitoring visit reviews, monitoring plan review); may include co-monitoring, compliance with protocol/regulatory requirements, monitoring training for CRO personnel, attending monitoring meetings, and assigned site monitoring.
- Review/oversee site KPIs, protocol deviations, and metrics; escalate risks/non-compliance and review SCAPAs/CAPAs and site audits with Quality Assurance.
- Support clinical study lead tracking regulatory submissions/approvals, recruitment/enrollment, and other assigned tasks.
- Proactively review EDC, generate queries, identify risks/decisions, implement mitigation, and solve operational challenges.
- Draft/adopt SOPs and ensure studies are “inspection ready”; may support regulatory inspections.
- Oversee assigned vendors; collaborate with internal teams for seamless trial execution and regular study updates.
- May review site/vendor invoicing and financial management; support TMF activities.
- Support onboarding and mentoring.
Required Education/Experience/Skills:
- 4+ years clinical operations experience; BS/BA (Life Sciences).
- 4+ years independent on-site monitoring (all visit types; incl. remote); 3+ years cardiac study experience in pharma sponsor environment preferred.
- Strong attention to detail; verbal/written/interpersonal/presentation skills.
- Familiarity with medical/scientific terminology.
- MS Office (incl. PPT); SmartSheet desirable.
- Knowledge of FDA/ICH/GCP.
- Ability to participate in strategic initiatives under general supervision.
- Highly productive, accountable, team-oriented.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off.
Application Instructions:
- Ongoing applications (no deadline).