Clinical Operations Coordinator – Front & Back Office
Nabi
Associate Director, Clinical Research Operations
GeneDx
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $153,053 - $191,317 per year
Job Level
Senior
About the role
- 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
Requirements
- 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
