Essential Document Pack (EDP) Reviewer - Clinical Trials - FSP

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Summary of Essential Functions: Essential Document Pack (EDP) reviewer is responsible for the review and approval of the country and site essential documents. The EDP contains at a minimum the most critical essential documents required for site activation. The documents required to be collected for each study site/country will be documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the EDP is reviewed for all required essential regulatory documents for completeness, accuracy and quality. The packs are reviewed by designated EDP reviewers who are independent from the study. Position SummaryThe Essential Document Pack (EDP) Reviewer is responsible for the independent review of country- and site-level essential document packages required to support clinical trial site activation. This is a hands-on clinical trial document review and compliance role. The EDP Reviewer assesses essential regulatory documents for completeness, accuracy, quality, and compliance with study-specific requirements, applicable SOPs, client requirements, and regulatory guidelines. The strongest candidates will have direct experience reviewing clinical trial essential/regulatory documents, supporting study or site start-up, or working with regulatory documentation required for site activation. Key ResponsibilitiesIndependently review country-level essential documents for completeness, accuracy, quality, and compliance with the applicable Essential Document Compliance checklist. Independently review site-level essential documents required for clinical trial site activation. Confirm that required essential regulatory documentation is present and meets applicable study, sponsor, SOP, and regulatory requirements. Identify documentation deficiencies, inconsistencies, missing information, or quality concerns. Communicate review outcomes and required corrections to EDP submitters and/or appropriate study team members. Review revised document packages to confirm identified deficiencies have been appropriately resolved. Communicate final review outcomes to Study Start-Up Specialists and other applicable stakeholders. Accurately track EDP review activities and outcomes in applicable systems and databases. Maintain current knowledge of company SOPs, client SOPs and directives, study-specific requirements, and applicable regulatory guidelines. Apply independent judgment when assessing whether clinical trial documentation meets established requirements. Partner effectively with study teams to support timely and compliant site activation. Minimum QualificationsBachelor's degree or equivalent combination of education and relevant experience. 2+ years of relevant clinical research experience, including hands-on experience with clinical trial regulatory or essential documentation. Experience reviewing clinical trial documentation for completeness, accuracy, quality, and/or regulatory compliance. Experience in one or more of the following areas: Clinical trial essential document review Study or site start-up Clinical regulatory documentation Site activation Regulatory start-up TMF/eTMF or equivalent clinical trial documentation Working knowledge of SOPs, clinical trial documentation requirements, and applicable regulatory guidelines. Ability to independently identify documentation deficiencies and communicate required corrections. Strong attention to detail, quality, and document accuracy. Strong written and verbal English communication skills; local language proficiency where applicable. Ability to work independently, exercise sound judgment, and manage multiple priorities and timelines. Strong analytical, investigative, and problem-solving skills. Proficiency with Microsoft Word, Excel, and PowerPoint, with the ability to learn new systems and technologies. Preferred ExperienceExperience working within a CRO, pharmaceutical, biotechnology, or other clinical research environment. Experience supporting multinational or country-level clinical trial start-up activities. Familiarity with global, regional, and country-specific clinical trial regulatory requirements. Experience reviewing Essential Document Packages, regulatory document checklists, or equivalent site activation documentation. Familiarity with ICH-GCP and clinical trial regulatory requirements. Experience communicating document deficiencies and working with study teams to achieve compliant deliverables. Compensation The estimated annualized pay range for this position in North Carolina is $93,000.00–$125,000.00.