Senior Clinical Research Associate - Cardiovascular (EDG-2025017)

Role Summary

Senior Clinical Research Associate - Cardiovascular. This role supports a growing Colorado-based Clinical Development team with highly complex and high-risk trials across multiple indications, overseeing site start-up, monitoring, and collaboration across internal functions to ensure compliant and efficient study execution.

Responsibilities

• Lead site start-up activities and contribute to feasibility.
• Collaborate with contracts team to review and negotiate site and vendor budgets/contracts.
• Develop and review study, patient, and site-facing documents (e.g., protocols, ICFs, study plans).
• Oversee contract CRA and CRO monitoring activities; may include on-site co-monitoring and training CRO personnel; attend monitoring meetings; may have assigned site monitoring responsibilities.
• Review site KPIs, protocol deviations, and metrics; escalate risks; collaborate with QA on SCAPAs/CAPAs and audits.
• Support clinical study progress by tracking regulatory submissions, recruitment, and enrollment.
• Review EDC for completeness, identify issues, generate queries; identify risks and mitigation strategies; provide guidance to ensure study execution.
• Assist in drafting SOPs and ensure studies are inspection-ready; participate in regulatory inspections as needed.
• Oversee assigned vendors and collaborate with internal teams to ensure seamless trial execution; provide regular study updates.
• May review site/vendor invoicing and financial management per agreements; support TMF activities.
• Support onboarding and mentoring of new department members.

Qualifications

• At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences).
• Minimum 4 years of independent on-site monitoring experience across all visit types, with at least 3 years in cardiac studies in a pharmaceutical sponsor environment (global pharma or biotech preferred).
• Excellent attention to detail, verbal, written, interpersonal and presentation skills.
• Familiarity with routine medical/scientific terminology.
• Proficiency with MS Office (including PowerPoint); Smart Sheet proficiency desirable.
• Knowledge of FDA, ICH Guidelines, and GCPs governing clinical trials.
• Ability to participate in departmental or interdepartmental strategic initiatives under general supervision.
• Highly productive, engaged and accountable; team-player in a fast-moving startup environment.

Education

• Bachelor’s degree in Life Sciences or related field.

Additional Requirements

• Travel: 20-50% travel.
• Location: Colorado-based, hybrid work arrangement.