Protocol Coordinator

Accountabilities: Clinical Protocol Development: Lead the development, drafting, review, and maintenance of clinical research protocols in collaboration with study chairs, scientific committees, investigators, statisticians, and other study team members. Document Coordination: Prepare and maintain study-related documentation, including protocol amendments, informed consent forms, youth information sheets, laboratory and pharmacy manuals, training materials, and other supplemental documents. Review and Approval Management: Coordinate internal and external review and approval processes throughout the clinical trial lifecycle, from initial study concepts to study closure. Study Planning and Activation: Establish development objectives, communicate deadlines, coordinate weekly study meetings, and facilitate kick-off discussions to ensure timely study activation. Scientific Documentation: Design experimental study schemas and therapy delivery maps, maintain standardized protocol language, and ensure all clinical and research requirements are accurately represented. Quality Assurance: Review case report forms and supporting documentation for consistency with approved protocols, address document-related queries, and ensure compliance with departmental procedures. Stakeholder Collaboration: Facilitate communication between investigators, study committees, research coordinators, institutional clinical research associates, and external research organizations. Study Management: Identify documentation inconsistencies, track protocol-related issues, coordinate necessary amendments, and prepare study updates for publication on relevant platforms. Administrative Coordination: Maintain accurate study records, monitor key milestones, attend scientific and operational meetings, and support additional research and documentation projects as needed. Requirements Bachelor's degree in a life sciences or related field, or an equivalent combination of education and experience, including four additional years of relevant professional experience. Previous experience in clinical research trials and clinical trial protocol development. Strong understanding of clinical trial components, including study methodology, statistics, informed consent, eligibility criteria, and adverse event reporting. Approximately 2–3 years of scientific writing experience involving clinical protocols, published manuscripts, research grants, or other scientific documentation is highly desirable. Experience in clinical research, life sciences, or a related scientific field is preferred. Demonstrated ability to research, interpret, analyze, and evaluate complex scientific information accurately. Excellent written and verbal communication skills, with strong attention to detail and the ability to translate technical information into clear documentation. Advanced computer literacy, particularly proficiency in Microsoft Word and other document-processing tools. Familiarity with medical terminology and clinical research documentation standards. Strong organizational and project coordination skills, including the ability to manage multiple deadlines and competing priorities. Ability to work independently while collaborating effectively with investigators, research professionals, and multidisciplinary teams. A proactive, adaptable, and detail-oriented approach to problem-solving and stakeholder communication. A master's degree in life sciences or a related discipline is preferred. Benefits Competitive annual salary: Full salary range of $64,542–$92,421, with a typical hiring range of $64,542–$78,482, depending on qualifications, experience, skills, and budget availability. Fully remote position: Work remotely from anywhere within the United States. Comprehensive healthcare: Medical, dental, and vision insurance options. Retirement savings: 401(k) plan. Paid time off: Accrued PTO and paid holidays. Financial and lifestyle support: Cell phone and internet stipends. Health and wellness: Wellness stipend and Employee Assistance Program (EAP). Flexible spending: Flexible Spending Account (FSA) options. Mission-driven work: Contribute to clinical research initiatives dedicated to advancing treatments and improving outcomes for children and adolescents with cancer. Professional impact: Join a collaborative research environment and help shape an important function within a growing organization.