The Sr. CRA role is integral to driving project success and a key role within the Clinical Operations function. This position will independently manage and monitor clinical trial sites, and will function as the Lead CRA on select projects. In the Lead role, this position will be responsible for providing direction to and training for other CRAs (FTEs, contractors and CRAs from Contract Research Organizations). They are responsible for ensuring that sites and CRAs operate in compliance with study protocols, company SOPs, ICH/GCP guidelines, and Federal Regulations
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Assist in managing all aspects of clinical studies for one or a small number of protocols
• Provide monitoring oversight by reviewing monitoring schedule, metrics and reports
• May oversee or manage clinical documentation and reports
• Participate in the maintenance of the internal Trial Master File (TMF) and periodically review or QC the CRO TMF(s) to ensure accuracy, completeness and adherence to agreed-upon structure
• Accurately update and maintain clinical systems within project timelines
• Manage clinical trial supply requisition and maintenance of tracking information
• Participate in and may facilitate clinical sub-team meetings
• Oversee the processing of site payments and vendor invoices
• Maintain tracking information for study activities, including Study Quality Metrics (SQM) and Key Performance Indicators (KPI)
• Partner with other functional areas to track clinical samples
• May assist with clinical data review
• Assist with informed consent development and review
• Occasionally perform centralized monitoring, site monitoring visits, co-monitoring or monitoring oversight visits to assess quality and compliance by site and site monitors
• Create and conduct training sessions including investigator meetings and team trainings
• Assist with study feasibility assessments for new protocols
• Completes assigned responsibilities in a quality and timely manner
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures
• Ability to travel for up to 30%
• Bachelor’s degree, preferably in areas such as biological sciences, health care management or life sciences research
• May require certification in assigned area.
• Requires a minimum of 4 years of related experience and/or combination of experience and education/training.
• Experience with site monitoring for drug studies (multiple phases of clinical research desirable)
• Understanding of the Trial Master File structure (TMF)
• Highly proficient in software applications such as Word, Excel, and PowerPoint
• Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
• Has a basic understanding of the drug development process and knowledge of FDA regulations and guidelines.
• Organizes and prioritizes numerous tasks and completes them under time constraints.
• Applies technical standards, principles, theories, concepts and techniques.
• Demonstrated success in problem solving.
• Experienced professional with a full understanding of area of specialization.
• Applies strong analytical and business communication skills.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Ability to constructively interact directly with clinical site personnel
• Develops relationships with senior internal and external personnel in area of expertise.