Senior Clinical Research Associate

September 16

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000

Description

• 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 • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues • Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed • Perform study-specific training with project team • Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data • Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies • Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines

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