CRA/CPM Study Start-Up and Monitoring Support (Contract Role)

An unnamed global medical device leader is seeking a Clinical Research Associate to support study start-up administration and regulatory work under a Clinical Project Manager. The role also conducts clinical monitoring visits and supports study timelines, budgets, and site-level inspection readiness.

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Responsibilities

• Assist with site feasibility assessments and qualification visits (SQV/PSV) for new studies
• Help prepare and route Clinical Trial Agreements (CTAs) and other site contracts for CPM and Legal review
• Support site budget tracking and invoice reconciliation
• Prepare IRB/EC submission packages and track approvals and amendments
• Support ICF development and site-specific customization
• Track start-up timelines and flag delays to the CPM
• Conduct SIV, IMV, and COV visits per protocol, ICH-GCP, and ISO 14155 for device trials
• Perform SDV and SDR under both 100% SDV and risk-based monitoring (RBM) frameworks
• Monitor device-specific compliance: accountability, maintenance logs, and complaint/malfunction reporting
• Identify protocol deviations and help sites plan corrective actions
• Support timely query resolution
• Maintain trip reports, visit logs, and CTMS documentation in real time
• Help maintain study timelines, risk registers, and enrollment forecasts
• Support budget tracking against contracted milestones
• Support inspection readiness and audit response at the site level

Preferred

• Prior experience monitoring medical device or combination product trials
• Familiarity with focused ultrasound, neurology, or other device-driven therapeutic areas

Benefits

• Remote work arrangement
• IT Engagement is your central hub for all your SAP needs and specializing in strategic solutions for the pharmaceutical, biotechnology, device and related industries.
• Bridgewater, New Jersey, USA
• https://itengagements.com
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Qualifications

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• 3+ years of clinical research experience spanning both study start-up support and monitoring
• GCP certification
• Exposure to CTAs, site budgets, and IRB/EC submissions, even in a supporting capacity
• Hands-on experience conducting PSV, SIV, IMV, and COV visits
• Experience with both 100% SDV and RBM models
• Proficiency with CTMS and EDC systems
• Comfortable supporting multiple sites/studies concurrently
• Prior experience monitoring medical device or combination product trials
• Familiarity with focused ultrasound, neurology, or other device-driven therapeutic areas
• 3+ years of clinical research experience spanning both study start-up support and monitoring.

Required skills

• CTMS, Clinical Practice (GCP), Clinical Research, Clinical Trial Agreements (CTAs), Clinical Trial Monitoring, Close-Out Visits (COV), EDC Systems, IRB/EC Submissions, Interim Monitoring Visits (IMV), Medical Device Trials, Pre-Study Visits (PSV), Risk-Based Monitoring (RBM), Site Budgets, Site Initiation Visits (SIV), Source Data Verification (SDV), Study Start-Up

Experience

• 3+ years