Senior Clinical Research Associate - Central Midwest

October 28

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Description

• The SCRA is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites • Ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs • Collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study activities • Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices • Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation • Develop collaborative relationships with investigative sites, and study vendors • Track enrollment status reports to ensure study sites stay on track to meet enrollment goals • Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team • Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues • Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies • Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards

Requirements

• Minimum of 4-6 years of relevant Clinical Operations experience • Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness