Senior Cardiac CRA

Position OverviewThe Senior Clinical Research Associate (CRA) will serve as the primary owner for assigned clinical sites, overseeing day-to-day site management, monitoring activities, and issue resolution for cardiovascular device studies involving Impella heart pump technology.This role requires a traditional, hands-on monitoring approach, including in-depth review of medical records, informed consent documentation, and safety data. The CRA is expected to independently identify risks, guide sites through corrective actions, and escalate thoughtfully when necessary.Key Responsibilities1. Site Management & OwnershipServe as the primary point of contact for assigned investigational sitesTake full ownership of site performance, beyond high-level monitoringProactively manage:Site questions and protocol clarificationsRetraining needsData quality concernsMonitoring follow-upsIdentify issues early and work independently to resolve them before escalating2. Clinical Monitoring (SDV & SDR)Conduct onsite monitoring visits focused on deep Source Data Verification (SDV) and Source Data Review (SDR)Review full medical records, not just EDC worksheetsEnsure:Accurate transcription of source dataProtocol complianceComplete and compliant documentationClearly articulate monitoring logic, including:How informed consent is reviewedHow eligibility and endpoint data are verified3. Protocol Compliance & Patient SafetyAct as the first line of defense to ensure sites:Enroll the correct patient populationsFollow protocol requirements preciselyReview medical histories and clinical documentation to identify:Adverse events (AEs)Serious adverse events (SAEs)Other safety signalsAssist sites in properly documenting and reporting safety events in accordance with protocol and regulatory expectations4. Communication & Team IntegrationParticipate in:Regular study team meetingsProject check-ins and updatesMaintain high transparency by:Copying the internal study team on all site-related communicationsProviding clear, timely updates on site status, risks, and progressOperate as an embedded team member rather than a siloed monitor5. Office-Based Administrative ResponsibilitiesApproximately 1-2 weeks per month are dedicated to office-based work, including:Query review and resolutionSite retraining preparation and follow-upMonitoring visit preparation and documentationFollow-up on action items identified during visitsOngoing site relationship managementThis time is critical to maintaining site quality and continuity between visits.Qualifications & ExperienceRequired Experience5-10 years of clinical monitoring experiencePrevious experience functioning at a Senior CRA levelStrong background in cardiovascular clinical studiesPreferred ExperienceMedical device trial experience (highly preferred)Understanding of device-specific regulatory and procedural nuancesExperience working:Directly with a sponsor orAt a smaller, high-touch CROCandidates whose background is limited to large, highly automated CRO environments may not be an ideal fit due to differences in monitoring depth and expectationsSomeone who has worked with us in the past.Core CompetenciesStrong critical-thinking and problem-solving skillsAbility to clearly explain:SDV/SDR methodologyInformed consent review processSafety event identificationHigh attention to detail with a patient-safety mindsetStrong written and verbal communication skillsComfort operating autonomously with accountabilityTravel & Work EnvironmentTravel Requirement: Approximately 60%Visit Frequency:Typically 2 monitoring visits per monthOccasionally 3 visits per monthOnly one visit in any given weekGeographic Scope:Primary regions include East Coast, South, and MidwestSome sites located in California and TexasWillingness to travel outside a traditional region as business needs arise is requiredTravel & Expense LogisticsTravel is booked through the Concur systemCRA uses a personal credit card to access preferred corporate ratesExpenses are reimbursed per company policy following submissionWhat Success Looks Like in This RoleSites feel supported, guided, and accountableIssues are identified early - not escalated lateMonitoring visits go beyond surface-level reviewThe CRA operates as a trusted extension of the internal study teamPatient safety and protocol integrity are consistently protected