Clinical Operations

• Lead and manage study start-up activities with cross-functional teams and external collaborators for prospective research studies, including identifying all requirements for study readiness\n• Coordinate the development of study-specific materials with cross-functional teams, including protocols, informed consent forms, research kits, and documents that support study conduct\n• Coordinate execution of research agreements and letters of support for applicable research projects.\n• Collaborate with laboratory, bioinformatics, and production teams to ensure awareness and readiness for processing and reporting of study samples\n• Develop and maintain detailed study timelines and trackers to ensure on-time delivery of study milestones\n• Facilitate regular project meetings, status updates, and issue resolution\n• Maintain comprehensive study documentation, including study trackers, meeting notes, and regulatory files\n• Partner with commercial and biopharma teams to support the review, start-up, and execution of research services projects\n• Manage central IRB submissions and renewals for GeneDx-sponsored research projects\n• Ensure research activities comply with IRB requirements, HIPAA, and internal SOPs\n•Bachelor’s degree in life sciences, public health, or a related field.\n•Minimum 3 years of experience in clinical research operations or project management. Experience in genomics, diagnostics, or biopharma preferred.\n•Strong understanding of clinical research processes, IRB submissions, and study documentation.\n•Knowledge of clinical research standards and compliance requirements preferred.\n•Proficiency in Microsoft Office Suite and project management tools preferred.\n•Excellent communication, organizational, and stakeholder management skills.\n•Attention to detail and commitment to producing high-quality work.\n•Ability to manage multiple projects simultaneously.\n•Good Clinical Practice and Human Subjects Research Certification preferred

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