Sr. Clinical Research Associate

Senior Clinical Research Associate (CRA) / CRA II

Cardiovascular Medical Device (Observational Study)

Position Overview

We are seeking an experienced Senior Clinical Research Associate (CRA) or a highly skilled CRA II to support a complex, high-intensity observational cardiovascular medical device study focused on patients with cardiogenic shock. This study involves the Impella device and is currently in the startup and active enrollment phase.

This role requires a proactive, detail-oriented professional capable of managing complex clinical data, navigating regulatory nuances such as waiver of consent, and operating effectively in fast-paced clinical environments.

Core Responsibilities

1. End-to-End Site Management

• Manage 4–5 assigned clinical sites across all study phases
• Oversee site performance, enrollment, compliance, and data quality
• Maintain and ensure completeness of Trial Master File (TMF) documentation
• Act as the primary point of contact for site personnel

2. Site Initiation & Monitoring

• Conduct Site Initiation Visits (SIVs) and train site staff on protocol and regulatory requirements
• Perform routine monitoring visits (onsite and remote)
• Identify, document, and resolve site issues, protocol deviations, and compliance risks
• Prepare monitoring reports and follow-up documentation

3. Complex Data Review & Verification

• Interpret and correlate complex hemodynamic and cardiovascular data
• Review catheterization (Cath) reports and detailed procedural logs
• Ensure accurate transcription and alignment between source documents and EDC systems
• Evaluate safety data and adverse events in alignment with protocol

4. Regulatory & Compliance Oversight

• Ensure compliance with GCP, regulatory requirements, and internal SOPs
• Manage challenges related to waiver of consent and de-identified/redacted source data
• Support audit readiness and participate in internal/external audits
• Review and amend informed consent documentation when applicable

5. Data Quality & Query Management

• Partner with data management and clinical teams to resolve queries
• Investigate discrepancies and implement corrective/preventive actions
• Identify trends in data quality, protocol adherence, and site performance

6. Cross-Functional Collaboration

• Participate in weekly core team meetings and CRA alignment sessions
• Provide insights on enrollment, compliance, and operational trends
• Collaborate with medical, data, and operational teams

7. Process Improvement & Leadership

• Identify operational inefficiencies and implement process improvements
• Provide mentorship, coaching, and training to junior CRAs
• Contribute to team initiatives and strategic projects

Required Qualifications

• Bachelor’s degree in a related field
• 5 years of clinical monitoring experience (CRA II or Senior CRA level)
• Strong experience in cardiovascular or medical device clinical trials
• Ability to interpret complex medical records and Cath lab reports
• Solid understanding of observational study regulations and waiver of consent
• Experience with Electronic Data Capture (EDC) systems and TMF management
• Excellent communication, analytical, and problem-solving skills
• Proficiency in Microsoft Office (Word, Excel, Adobe)
• Ability to travel up to 65%

Preferred Qualifications

• Nursing background (especially cardiac or Cath lab experience)
• Direct experience with cardiogenic shock studies
• Experience in high-acuity or ICU-related clinical environments
• Clinical Research certification (ACRP, SOCRA, or equivalent)
• Prior experience in medical device or regulated industry settings

Work Structure & Logistics

• Geographic Coverage:
• One CRA based on the West Coast
• One CRA based in Central or Eastern regions
• Working Hours:Availability required during Eastern Time business hours (8:00 AM – 5:00 PM ET)
• Weekly core team meeting at 9:00 AM ET
• Travel: Up to 65% (approximately 3 days per week)
• Flexibility for short-notice travel required

Key Responsibilities

• End to End site manager, this includes monitoring patient data and regulatory documents as well routine/day-to-day site management activities for all assigned sites.
• Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
• Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
• Perform study start-up and study conduct activities, managing, and communicating the status of study progress and activities
• Partner with cross-functional team (e.g., clinical data management, medical teams, field teams) with query management, data reviews and resolution.
• Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
• Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve efficiencies within and across related functional areas
• Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
• Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
• Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
• Contribute to team projects.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Edit/amend informed consent documents
• Provide coaching and training to junior employees