Fortrea is a leading global contract research organization (CRO) with a commitment to scientific rigor and decades of clinical development experience. We provide a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas for pharmaceutical, biotechnology, and medical device customers. Operating in over 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.
Site Monitoring: Oversee all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits. Liaise with vendors and perform additional duties as assigned.
Site Management: Manage all site management tasks as prescribed in project plans.
On-Site Monitoring: Ensure study staff receive the necessary materials and instructions for safely enrolling patients in the study.
Patient Protection: Verify adherence to informed consent procedures and protocol requirements in compliance with applicable regulations.
Data Integrity: Conduct careful source document reviews to ensure the accuracy of data submitted on Case Report Forms (CRFs) and other data collection tools.
Data Monitoring: Monitor data for any missing or implausible entries.
Resource Management: Ensure efficient use of Sponsor and Fortrea resources, adhering to SOPs and established guidelines, including economical travel management.
Audit Readiness: Maintain site-level audit readiness.
Travel Requirements: Travel, including air travel, is an essential function of this role.
Reporting: Prepare accurate and timely trip reports.
Registry Management: Manage all aspects of registry tasks as specified in project plans.
Feasibility Work: Conduct feasibility assessments when requested.
Quality Control: Participate in and follow up on Quality Control Visits (QC) as required.
Investigator Recruitment: Assist in recruiting potential investigators, preparing EC submissions, and notifying regulatory authorities.
SAE Tracking: Track and follow up on Serious Adverse Event (SAE) reporting, including report production and narrative follow-ups.
CRF Review: Independently perform CRF reviews, query generation, and resolution against established data review guidelines.
Training: Assist in training new employees, including co-monitoring.
Project Coordination: Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.
Additional Duties: Perform other duties as assigned by management.
Minimum Required:
Minimum Required:
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.
Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
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