As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Responsibilities:
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Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks.
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Support system compliance and system data entry, as applicable
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File required task-related documentation in the Electronic Trial Master File (eTMF)
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Develop and/or review initial/amended Core Informed Consent Forms (ICFs)
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Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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Customize initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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Review and approve investigator essential documents in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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Perform investigator debarment/inspection listing checks.
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Develop and/or review advertisements in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
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Support Initial/Amendment submissions to the Central IRB/IEC for North America
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Create the CDA Master template and review/approval of fully executed CDAs.
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Protocol review in compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
Minimum Required:
– Years of experience in the job discipline: 06-08 Years
– Other required work-related experiences:
• Demonstrated ability to plan, prioritize, organize and communicate effectively. • Demonstrated ability to pay attention to detail.
• Strong interpersonal skills with ability to work well with others.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.
• Ability to Influence and Lead the processes & process improvement initiatives. • Ability to facilitate meetings.
• Ability to mentor and train others
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, 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.
