Senior Clinical Research Coordinator - Multi-Center Trials

Children's Hospital Medical Center; United States; On-site; USD 63,000 - 81,000; Full time

Job summary

Children's Hospital Medical Center in the United States is seeking a Clinical Research Coordinator to support a broad portfolio of Otolaryngology studies, including hearing loss, gene therapy, voice, airway, and sleep apnea. The position handles a wide range of projects within a fast-paced research environment.

The Otolaryngology research team is comprised of approximately 90 active studies, spanning retrospective projects to investigator-initiated and industry-sponsored trials, offering

Responsibilities

• Study Conduct/ Clinical Research Practice - 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 work flow 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, proce
• Regulatory Compliance and Documentation - 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 standar
• Recruitment/Enrollment/Retention - 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 time‑lines. 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.
• Data 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 an

Job description

Children's Hospital Medical Center in the United States is seeking a Clinical Research Coordinator to support a broad portfolio of Otolaryngology studies, including hearing loss, gene therapy, voice, airway, and sleep apnea. The position handles a wide range of projects within a fast-paced research environment.

The Otolaryngology research team is comprised of approximately 90 active studies, spanning retrospective projects to investigator-initiated and industry-sponsored trials, offering