Clinical Research Associate (CRA) - Oncology (Remote)

Job Summary

Required Qualifications

• •Reside in Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, or Pennsylvania
• •Current driver's license
• •Associate's degree, certificate, or equivalent in a scientific/healthcare discipline
• •Bachelor's degree or above
• •At least 5 years of relevant experience in the healthcare field
• •At least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO
• •Fluent in Local Languages and English (verbal and written)
• •Excellent communication skills
• •Ability to understand and present technical information effectively
• •Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• •Good understanding of Global, Country/Regional Clinical Research Guidelines
• •Hands on knowledge of Good Documentation Practices
• •Proven Skills in Site Management including management of site performance and patient recruitment
• •Demonstrated high level of monitoring skill with independent professional judgment
• •Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices)
• •Ability to adapt to new IT applications on various devices
• •Ability to understand and analyze data/metrics and act appropriately
• •Capable of managing complex issues, works in a solution-oriented manner
• •Ability to perform root cause analysis and implement preventative and corrective action
• •Effective time management, organizational and interpersonal skills
• •Conflict management, problem solving skills
• •Ability to work highly independently across multiple protocols, sites and therapy areas
• •High sense of accountability / urgency
• •Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• •Works effectively in a matrix multicultural environment
• •Ability to establish and maintain culturally sensitive working relationships
• •Commitment to Customer focus
• •High quality and compliance mind-set
• •Positive mindset, growth mindset, capable of working independently and being self-driven
• •Professional demeanor and communication consistent with organizational policies and practices
• •Ability to travel domestically and internationally approximately 65%-75% of working time
• •Expected travelling ~2-3 days/week
• •Ability to understand and present technical information effectively
• •Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• •Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• •Hands on knowledge of Good Documentation Practices
• •Proven Skills in Site Management including management of site performance and patient recruitment
• •Demonstrated high level of monitoring skill with independent professional judgment
• •Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices)
• •Ability to adapt to new IT applications on various devices
• •Ability to understand and analyze data/metrics and act appropriately
• •Capable of managing complex issues, works in a solution-oriented manner
• •Performs root cause analysis and implements preventative and corrective action
• •Effective time management, organizational and interpersonal skills
• •Conflict management, problem solving skills
• •Ability to work highly independently across multiple protocols, sites and therapy areas
• •High sense of accountability / urgency
• •Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• •Works effectively in a matrix multicultural environment
• •Ability to establish and maintain culturally sensitive working relationships
• •Demonstrates commitment to Customer focus
• •Works with high quality and compliance mind-set
• •Positive mindset, growth mindset, capable of working independently and being self-driven
• •Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
• •Accountability
• •Adaptability
• •Administrative Policies
• •Adverse Event Reporting System
• •Clinical Research Methods
• •Clinical Site Management
• •Clinical Study Management
• •Clinical Trial Planning
• •Clinical Trials
• •Clinical Trials Monitoring
• •Core Competencies
• •Data Analysis
• •Data Reporting
• •Early Clinical Development
• •Good Clinical Data Management Practice (GCDMP)
• •Good Clinical Practice (GCP)
• •IT Change Management
• •Oncology
• •Pharmacovigilance
• •Policy Development
• •Preventive Action
• •Protocol Adherence
• •Regulatory Affairs Compliance
• •Regulatory Compliance