Clinical Research Coordinator lll or IV - Bone Marrow Transplant

• Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials.
• Develop & implement associated projects related to studies under the guidance of the principal investigator.
• Collaborate effectively with others to ensure proper progress & completion of studies.
• Assist other members by educating, providing resources, & consulting on difficult protocols or projects.
• Indirectly (or directly) supervise other CRCs.
• Train new staff in preparation & conduct of clinical trials.
• Provide oversight and guidance as needed to research staff.
• Collaborate on multiple projects or studies, and support other staff or the workflow involved in research work.
• Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• Collect and process specimens to meet study requirements.
• Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.

• Coordinate complex regulatory activities & periodic internal self-audit of records.
• May lead staff in regulatory activities.
• Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties.
• Provide oversight and guidance for project procurements.
• Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
• Organize the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, or consultants, and coordinate the process to meet these requirements.
• Act as a resource for regulatory affairs.
• Apply federal regulations; state and local law; and CCHMC and division policies and standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
• Ensure the documentation of regulatory activities in appropriate systems.
• Coordinate and maintain up-to-date and accurate written and electronic records and files.

• Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects.
• Oversee study staff performance.
• Proactively take initiative to ensure recruitment stays on track with the project timelines. Implement successful plan to identify potential participants.
• Engage study staff to assist in identifying and enrolling participants.
• Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
• Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly.
• Create and maintain a detailed tracking system for participants considered for enrollment.
• Track progress at regular intervals and report out to PI and or management.

• Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process.
• Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
• Create Data Dictionary, as per protocol and in conjunction with principal investigator and statistician.
• Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.
• Maintain and audit data, providing status and activity reports as required.
• Organize data to analyze, identify, and report trends. Review reports, tables, and listings.
• Assist in data analysis and maintain record keeping and data storage for clinical research studies. Maintain master database files for clinical research protocols.
• Prepare reports from validation studies of clinical research projects.
• Evaluate and resolve issues regarding contents of reports.
• Ensure quality of data submitted from study sites and assure timely submission of data.
• Oversee the processing of laboratory and other external data.

Cincinnati Children's Hospital Medical Center