Clinical Research Associate

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 escalate thoughtfully when necessary.

CRA's will be involved cardiovascular studies. Specifically, the studies utilize Impella heart pump devices (Abiomed), which are used in various cardiac procedures.

Key Responsibilities

1. Site Management & Ownership

• 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

2. 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 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

3. Protocol Compliance & Patient Safety

• 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

4. Communication & Team Integration

• 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

5. Office-Based Administrative Responsibilities

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.

Qualifications & Experience

Required Experience

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

Preferred Experience

• 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
• Someone who has worked with us in the past.

Core Competencies

• 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 & Work Environment

• 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 & Expense Logistics

• 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

What Success Looks Like in This Role

• Sites feel supported, guided, and accountable
• Issues are identified early — not escalated late
• Monitoring visits go beyond surface-level review
• The CRA operates as a trusted extension of the internal study team
• Patient safety and protocol integrity are consistently protected