Essential Document Pack Reviewer – Clinical Trials – FSP

This is a fully remote position, open to applicants in United States, +2 more states.

📋 Description

• Conduct independent reviews of country-level essential documents to ensure completeness, accuracy, quality, and adherence to the Essential Document Compliance checklist.

• Perform independent assessments of site-level essential documents necessary for the activation of clinical trial sites.

• Verify that essential regulatory documentation aligns with study, sponsor, SOP, and regulatory requirements.

• Detect documentation deficiencies, inconsistencies, missing information, and quality issues.

• Relay review results and necessary corrections to submitters and members of the study team.

• Review updated document packages to ensure that identified deficiencies have been addressed.

• Communicate final review results to Study Start-Up Specialists and other stakeholders.

• Monitor EDP review activities and outcomes within systems and databases.

• Stay updated on SOPs, study requirements, and regulatory guidelines.

• Utilize independent judgment to evaluate clinical trial documentation.

• Collaborate with study teams to facilitate timely and compliant site activation.

⛳️ Requirements

• A Bachelor's degree or an equivalent combination of education and relevant experience.

• A minimum of 2 years of pertinent clinical research experience, including direct involvement with clinical trial regulatory or essential documentation.

• Proficiency in reviewing clinical trial documentation for completeness, accuracy, quality, and/or regulatory compliance.

• Experience in areas such as clinical trial essential document review, study or site start-up, clinical regulatory documentation, site activation, regulatory start-up, or TMF/eTMF documentation.

• Solid understanding of SOPs, clinical trial documentation requirements, and relevant regulatory guidelines.

• Capability to identify documentation deficiencies and independently communicate necessary corrections.

• Excellent attention to detail, quality, and document accuracy.

• Strong written and verbal communication skills in English; proficiency in local languages when applicable.

• Ability to operate autonomously, exercise sound judgment, and manage multiple priorities and timelines effectively.

• Strong analytical, investigative, and problem-solving abilities.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Preferred: experience within a CRO, pharmaceutical, biotechnology, or clinical research setting.

• Preferred: experience with multinational or country-level clinical trial start-up processes.

• Preferred: familiarity with ICH-GCP and global, regional, and country-specific regulatory requirements.

🏝️ Benefits

• Reasonable accommodation for individuals with disabilities.

• Equal Opportunity Employer.