Role Description
The Clinical Research Associate is responsible for the following:
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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
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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.
Qualifications
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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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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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Current driver’s license required.
Requirements
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Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
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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.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
