Senior Clinical Research Associate - Cardiovascular (In-House)

Key Responsibilities:
- Lead site start-up activities (oversee CRO start-up, review essential document packages, site initiation materials, vendor training, participate in initiation visits) and support feasibility as needed.
- Collaborate with the contracts team to review and negotiate site/vendor budgets/contracts.
- Develop and review study/patient/site-facing documents (protocols, ICFs, study plans).
- Oversee Edgewise contract CRA and/or CRO monitoring activities (visit schedules, monitoring reviews, monitoring plan review); may include on-site co-monitoring, monitoring training support, and CRO monitoring meeting attendance.
- Review site KPIs, protocol deviations, and metrics; escalate risks/non-compliance; support SCAPAs/CAPAs and site audits with Quality.
- Support study progress tracking (regulatory submissions/approvals, recruitment/enrollment, and assigned tasks).
- Proactively review EDC for completeness/issues; generate queries; identify study-level risks/decisions and mitigations; address operational challenges.
- Contribute to drafting and adhering to Clinical Operations SOPs to ensure studies are inspection ready; may support inspections.
- Oversee assigned vendors.
- Coordinate with internal teams (Clinical Ops, Regulatory, Data Mgmt, Medical, CMC) and provide study updates.
- May oversee site/vendor invoicing and financial management per trial agreement/scope.
- Support TMF activities (e.g., TMF index/document provision).
- 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; includes remote); 3+ years cardiac studies preferred (pharma biotech/global pharma preferred).
- Strong attention to detail; verbal/written/interpersonal/presentation skills.
- Familiarity with medical/scientific terminology.
- MS Office proficiency (incl. PowerPoint); SmartSheet desirable.
- Knowledge of FDA/ICH/GCP.
- Ability to participate in strategic initiatives under general supervision.
- Productive, accountable; team-player in a fast-moving start-up.

Application Instructions:
- Apply on an ongoing basis; Edgewise does not accept resumes from recruitment agencies. Do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for fees related to unsolicited resumes.

Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) with match, and paid time off.