Senior Clinical Research Associate

Role Summary

The SCRA is primarily a site monitor responsible for the management and oversight of assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams by supporting day-to-day clinical study activities, provides mentoring to other CRA team members, and seeks opportunities to lead and drive improvements within the Site Management group and across the Americas region.

Responsibilities

• 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
• Work with CTOMs and CST to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards
• Collaborate with CST and clinical study sites to ensure timely delivery of study milestones
• Provide support for study sites and CRAs with audits/inspections preparation/responses and quality issues, and follow-through with audit/inspection findings to resolution
• Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff

Skills

• Efficient in Microsoft Word, Excel, PowerPoint and Outlook
• Familiar with industry CTMS and data management systems

Qualifications

• Understands clinical trial processes with thorough knowledge of ICH and regulatory guidelines
• Required: Minimum of 4-6 years of relevant Clinical Operations experience
• Required: 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

Education

• BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience. Experience in global oncology trials preferred.

Additional Requirements

• Travel: up to 40-60% time