Clinical Research Associate - Oncology - Southeast, South, or Northeast US - FSP

Job Summary

The Clinical Research Associate is responsible for the following:

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Key Accountabilities
• Site Management Responsibilities
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
• Gains an in-depth understanding of the study protocol and related procedures
• Collaborates with other sponsor roles to manage various tasks
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
• Participates and provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
• Collsues, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
• Team Development and Support
• Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
• Supports and/or leads audits/inspection activities as needed
• Performs co-monitoring visits where appropriate

Skills

• Fluent in local languages and English (verbal and written) and excellent communication skills, including the 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 judgement
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Able to understand and analyze data/metrics and act appropriately
• Capable of managing complex issues, working 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
• Demonstrated high level of monitoring skill with independent professional judgement
• Able 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
• Works with high quality and compliance mindset
• 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

Knowledge & Experience

• Minimum 2 years of direct on site monitoring experience in biotech/pharma/CRO organization
• Oncology monitoring experience required

Education

• Bachelor’s degree in science and /or biology preferred