Job Purpose:
The Clinical Research Associate (CRA) is responsible for the implementation, monitoring, and summarization of clinical trials in compliance with protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and Standard Operating Procedures (SOPs) to ensure patient safety.
Essential Responsibilities:
• Serve as the primary liaison for assigned study sites, conveying project information, answering questions, and resolving site-related issues in accordance with the clinical monitoring plan
• Develop a thorough understanding of study management tasks and responsibilities necessary to comply with protocol/regulatory requirements and applicable SOPs
• Attend Investigator Meetings and study-specific training for assigned trials
• Have comprehensive knowledge of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites
• Complete pre-study qualification visits, site initiation visits, routine monitoring, and close-out visits within established timelines, documents activities in reports in accordance with applicable SOPs and plans
• Develop and maintain strong collaborative working relationships with clinical investigative sites
• Ensure the trial site’s adequacy and personnel qualifications on an ongoing basis
• Develop and execute corrective action plans at the site level, proportionate to the risks identified
• Accountable for data integrity, patient safety, and regulatory compliance for all assigned sites
• Monitor recruitment and data quality on-site and remotely through systems and communication with sites
• Responsible for ongoing data review and source data verification to study-specific targets and deadlines
• Collaborate with data management to plan and meet data cut and lock deadlines
• Perform on-site drug accountability, reconciliation, and return when applicable
• Verify that trial product receipt, handling, accounting, and storage meets protocol requirements
• Assist the study team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation
Knowledge & Experience:
• A minimum of 2 years of on-site monitoring experience
• Recent experience with remote monitoring or risk-based monitoring preferred
• A minimum of 4 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, Contract Research Organization (CRO), and/or healthcare setting preferred
• Minimum of bachelor’s degree in life sciences or health-related sciences
• Proficient in Microsoft Office suite (Outlook, Word, Excel, and PowerPoint); familiarity with EDC, CTMS, and document management systems
• Overnight travel ranging from 30 – 80%
• May require physical presence in the corporate office up to a few times per month; otherwise, mainly home-based
• A core understanding of GCP as it relates to clinical trial monitoring
• Demonstrate a core understanding of medical terminology and clinical trial activities in relation to the execution of a clinical development plan
• Oncology experience preferred
Technical and Professional Competencies:
• Excellent written and verbal communication skills; quick learner; able to handle multiple studies and aggressive timelines
• Strong interpersonal skills
• Seeks out opportunities to take on tasks outside of the typical CRA role when required
• Great team player and comfortable working in a small company setting
• Thrives in an entrepreneurial team environment
• Self- Starter able to interact with global scientific, clinical, and marketing teams