Senior Cardiac CRA

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Position Overview

The 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 elevate thoughtfully when necessary.

• Serve as the primary point of contact for assigned investigational sites
• Take full ownership of site performance, beyond high‑level monitoring
• Proactively manage:
  • Site questions and protocol clarifications
  • Retraining needs
  • Data quality concerns
  • Monitoring follow‑ups
• Identify issues early and work independently to resolve them before escalating

• Conduct onsite monitoring visits focused on deep Source Data Verification (SDV) and Source Data Review (SDR)
• Review full medical records
  , not just EDC worksheets
• Ensure:
  • Accurate transcription of source data
  • Protocol compliance
  • Complete and compliant documentation
• Clearly articulate monitoring logic, including:
  • How informed consent is reviewed
  • How eligibility and endpoint data are verified

• Act as the first line of defense to ensure sites:
  • Enroll the correct patient populations
  • Follow protocol requirements precisely
• Review medical histories and clinical documentation to identify:
  • Adverse events (AEs)
  • Serious adverse events (SAEs)
  • Other safety signals
• Assist sites in properly documenting and reporting safety events in accordance with protocol and regulatory expectations

• Participate in:
  • Regular study team meetings
  • Project check‑ins and updates
• Maintain high transparency by:
  • Copying the internal study team on all site‑related communications
  • Providing clear, timely updates on site status, risks, and progress
• Operate as an embedded team member rather than a siloed monitor

Approximately 1–2 weeks per month are dedicated to office‑based work, including:

• Query review and resolution
• Site retraining preparation and follow‑up
• Monitoring visit preparation and documentation
• Follow‑up on action items identified during visits
• Ongoing site relationship management

This time is critical to maintaining site quality and continuity between visits.

• 5–10 years of clinical monitoring experience
• Previous experience functioning at a Senior CRA level
• Strong background in cardiovascular clinical studies

• Medical device trial experience (highly preferred)
  • Understanding of device‑specific regulatory and procedural nuances
• Experience working:
  • Directly with a sponsor or
  • At a smaller, high‑touch CRO
• Candidates whose background is limited to large, highly automated CRO environments may not be an ideal fit due to differences in monitoring depth and expectations

• Strong critical‑thinking and problem‑solving skills
• Ability to clearly explain:
  • SDV/SDR methodology
  • Informed consent review process
  • Safety event identification
• High attention to detail with a patient‑safety mindset
• Strong written and verbal communication skills
• Comfort operating autonomously with accountability

• Travel Requirement: Approximately 60%
• Visit Frequency:
  • Typically 2 monitoring visits per month
  • Occasionally 3 visits per month
  • Only one visit in any given week
• Geographic Scope:
  • Primary regions include East Coast, South, and Midwest
  • Some sites located in California and Texas
  • Willingness to travel outside a traditional region as business needs arise is required

• Travel is booked through the Concur system
• CRA uses a personal credit card to access preferred corporate rates
• Expenses are reimbursed per company policy following submission

• Start Date: March
• Duration: 12-month contract with strong likelihood of extension into 2026
• Work Hours: Approximately 40 hours per week
  • Natura…