Document Review Specialist II, US Remote Based

📋 Description

• • As a Document Review Specialist II at Fortrea Holdings Inc., you will play a critical role in ensuring the integrity and compliance of clinical trial documentation, contributing directly to the successful execution of global research projects.
• • This position is a full-time, remote, exempt opportunity based in the US, offering the flexibility to work from home while being an integral part of a world-leading team.
• • Your primary responsibility will involve the meticulous review of Investigator Packages, both initial and amended, to guarantee adherence to all pertinent regulatory requirements before a clinical trial site is authorized to begin enrolling patients.
• • You will also conduct thorough reviews of Core, Country, and Site Informed Consent Forms, verifying their compliance with sponsor mandates, local regulatory stipulations, and Good Clinical Practice (GCP) guidelines.
• • The role extends to reviewing Patient Recruiting materials, such as advertisements, ensuring they meet sponsor requirements, local regulations, and GCP standards.
• • A key aspect of your work will be the review of the Core Protocol, assessing its completeness, thoroughness, and compliance with GCP guidelines.
• • You will be responsible for accurately filing essential documents, including Informed Consent Forms, Patient Recruiting materials, and Investigator Package approval documentation, within the Trial Master File (TMF) and electronic TMF (eTMF).
• • A significant part of the Document Review Specialist II role involves drafting comprehensive Investigator Package Plans. These plans will meticulously document the required quality of documents within Investigator Packages, adhering to established Standard Operating Procedures (SOPs) with oversight from your manager.
• • You will serve as a mentor for lower-level staff, providing guidance and training on the review processes for Informed Consent Forms and Investigator Packages, as outlined in the mentoring plan.
• • This role requires a proactive approach to identifying and addressing any discrepancies or compliance issues within the documentation, escalating them as necessary.
• • You will contribute to the continuous improvement of document review processes by providing feedback and suggestions based on your experience.
• • The position demands a strong understanding of regulatory landscapes, including ICH, FDA, IRB/IEC, and other relevant guidelines, ensuring all documentation meets the highest standards of quality and compliance.
• • You will collaborate effectively with internal teams, including regulatory affairs, clinical operations, and project management, to ensure seamless document flow and approval.
• • Maintaining accurate and up-to-date records is paramount, ensuring all documentation is properly organized and accessible for audits and inspections.
• • The role requires a commitment to professional development, staying abreast of evolving regulatory requirements and best practices in clinical research documentation.
• • You will be expected to manage your workload efficiently, prioritizing tasks to meet deadlines and project timelines in a dynamic environment.
• • This position offers the opportunity to gain extensive experience in clinical trial operations and regulatory compliance within a reputable organization.
• • Your contributions will directly impact the efficiency and success of clinical trials, ultimately supporting the development of new therapies.
• • You will be part of an energetic and team-oriented workplace, fostering a collaborative and supportive environment.
• • Exposure within a world-leading team provides opportunities for professional growth and learning from experienced professionals in the field.
• • The role involves working with various computer software, both in-house and off-the-shelf, requiring adaptability and technical proficiency.
• • You will be expected to perform other duties as needed or assigned, demonstrating flexibility and a willingness to support the team's objectives.