Key Accountabilities:
Site Management Responsibilities
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Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
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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
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Gains an in-depth understanding of the study protocol and related procedures
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Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
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Participates and provides inputs on site selection and validation activities
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Performs remote and on-site monitoring & oversight activities using various tools to ensure:
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Data generated at site are complete, accurate and unbiased
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Subjects’ right, safety and well-being are protected
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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
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Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
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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
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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
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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
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Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
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Supports and/or leads audits/inspection activities as needed
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Performs co-monitoring visits where appropriate
Compliance with Parexel Standards
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Complies with required training curriculum
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Completes timesheets accurately as required
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Submits expense reports as required
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Updates CV as required
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Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements
Skills:
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Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
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Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
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Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
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Hands on knowledge of Good Documentation Practices
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Proven skills in Site Management including management of site performance and patient recruitment
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Demonstrated high level of monitoring skill with independent professional judgement
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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
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Ability to understand and analyze data/metrics and act appropriately
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Capable of managing complex issues, working solution – oriented manner
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Performs root cause analysis and implements preventative and corrective action
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Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
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Demonstrated high level of monitoring skill with independent professional judgement
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Able to work highly independently across multiple protocols, sites, and therapy areas
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High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
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Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
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Demonstrates commitment to Customer focus
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Works with high quality and compliance mindset
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Positive mindset, growth mindset, capable of working independently and being self-driven
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Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
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Ability to travel domestically and internationally approximately 65%-75% of working time
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Expected travelling ~2-3 days/week
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Current driver’s license required
Knowledge and Experience:
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Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.
Education:
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Bachelor’s degree preferred with a strong emphasis in science and /or biology
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