Clinical Research Coordinator IV - Bone Marrow Transplantation

Job Responsibilities Study Conduct / Clinical Research Practice – Serve as a resource for all aspects of conducting complex, multi‑center clinical trials. Develop and implement projects under the principal investigator’s guidance. Collaborate with team members to ensure timely progress and completion of studies. Educate, provide resources, and consult on challenging protocols or projects. Supervise other CRCs as needed. Train new staff on trial preparation and conduct. Provide oversight to research staff throughout the trial lifecycle. Collect and process specimens to meet study requirements, coordinating with other divisions for proper handling, processing, storage, and tracking. Regulatory Compliance and Documentation – Coordinate complex regulatory activities and periodic internal self‑audits of records. Oversee preparation, review, submission, and maintenance of regulatory documents, ensuring accuracy and timeliness. Provide oversight for project procurements and participate in monitor visits, audits, and quality reviews. Organize the review, correspondence, and approval of human research protocols, including study closeout. Determine additional regulatory requirements and coordinate the process to satisfy them. Apply federal, state, local regulations, and institutional policies to promote ethical research practices. Maintain up‑to‑date written and electronic records. Recruitment/Enrollment/Retention – Prepare staff for recruitment and enrollment on medium to large, complex projects. Oversee staff performance and proactively drive recruitment to stay on schedule. Develop and implement plans to identify potential participants through advertisements, chart reviews, or clinic schedule monitoring. Create and maintain a detailed tracking system for prospective participants, reporting progress to the PI and management. Data Management – Oversee data entry and validation to ensure accuracy, quality, and compliance. Create case report forms (CRFs) and data dictionaries in collaboration with team members. Support data‑management processes, addressing queries from data managers, statisticians, and sponsors. Maintain and audit data, provide status reports, and analyze trends. Review reports, tables, and listings, assist in data analysis, and maintain master database files and laboratory data processing. Job Qualifications Bachelor’s degree in a related field with 3+ years of experience, or a Master’s degree with 2+ years of experience. Certified Clinical Research Coordinator within 18 months of external hire (SOCRA or ASCP). Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability, or protected veteran status. EEO/Veteran/Disability #J-18808-Ljbffr Cincinnati Children's Office of Academic Affairs and Career Development