Sr Specialist, Document Review

Fortrea

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.

Document review Senior Specialist provides full and independent document review support in creation and review of global project and country regulatory documents. Document review Senior Specialist responds to CAPA’s and mentors lower-level staff.
 

Summary of Responsibilities:
• Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial
• Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Review Core Protocol for thoroughness and completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
• File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
• Draft Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP.
• Finalize Investigator Package Plans following the available SOP and obtaining review and approval of the plan from the necessary individuals defined in the SOP.
• Provide responses for Corrective and Preventative Actions (CAPAs) related to Document 
Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review.
• Review Country and Site Document Review activities within the Start-up Plan to ensure the requirements outlined in the plan meet regulatory requirements and follow departmental processes.
• Act as Document Review mentor for lower-level staff and help train lower-level staff on Document Review processes and expectations
• Oversee Local Investigator Package reviewers work for a specific country.
• Serve on SOP Review Team(s) as expert in Document Review processes and expectations.
• Serve as a Subject Matter Expert for partnership processes on Document Review activities such as Informed Consent Form review and Investigator Package review

• Provide back-up support for managers when necessary.
• And all other duties as needed or assigned

Qualifications (Minimum Required):
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required): 
• Expert knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines. 
• 5 years’ work experience in clinical research

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.

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