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
Supporting Activitiesmay include but not limited to the following
- 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
- 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
- Subjects9 rights, 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
- Collects, 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
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines
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
- Ability 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.
- Demonstrates 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
- Ability to travel domestically and internationally approximately 65%-75% of working time
- Expected travelling ~2-3 days/week
- Current driver9s license required
Knowledge and Experience:
- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Oncology monitoring experience required
Education:
- Bachelor9s degree preferred with a strong emphasis in science and /or biology
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