IV - Otolaryngology Department

Cincinnati Children's

9d•$63,086 - $80,558•Onsite

About The Position

The Otolaryngology research team is seeking a motivated Clinical Research Coordinator to support a broad portfolio of studies in areas such as hearing loss, gene therapy, voice, airway, sleep apnea, and aerodigestive conditions. The team has approximately 90 active studies, ranging from retrospective projects to investigator-initiated and industry-sponsored clinical trials. The role offers hands-on experience across many aspects of clinical research and is suited to someone who is detail-oriented, eager to learn, receptive to feedback, and excited to contribute in a collaborative, fast-paced research environment. The coordinator supports complex and multi-center clinical trials, including study conduct, regulatory compliance, participant recruitment and retention, and data management. Depending on level, the position may provide oversight and guidance to research staff, train new staff, coordinate regulatory submissions and reviews, and oversee study data and specimen handling.

Requirements

CRC II: High school diploma or equivalent and 2 years of work experience in a related job discipline.
CRC III: Bachelor's degree in a related field and 1 year of directly related work experience, or a master's degree in a related field.
CRC IV: Bachelor's degree in a related field and 3 years of experience in a related job discipline, or a master's degree and 2 years of experience in a related job discipline.
CRC IV: Certified Clinical Research Coordinator within 18 months of external hire date.

Nice To Haves

CRC II: Bachelor's degree in a related field preferred.

Responsibilities

Serve as a resource for conducting complex and multi-center clinical trials, and develop and implement related study projects under the guidance of the principal investigator.
Collaborate with colleagues to support study progress and completion, educate and consult with staff on protocols and projects, and support research workflows.
Indirectly or directly supervise, train, and provide oversight and guidance to research staff.
Collect and process specimens, coordinating with other divisions on handling, processing, storage, and tracking according to study requirements.
Coordinate complex regulatory activities and periodic internal self-audits; provide oversight for regulatory preparation, review, submission, maintenance, and documentation.
Coordinate and participate in monitor visits, audits, and internal and external quality reviews.
Organize review, correspondence, and approval of human research protocols with regulatory authorities, including study closeout; identify additional review requirements and coordinate them.
Apply federal, state, local, institutional, and divisional regulations, policies, and standard operating procedures to support ethical research and compliance.
Prepare study staff for recruitment and enrollment, oversee staff performance, and take initiative to keep recruitment on schedule.
Identify potential participants, create and maintain participant tracking systems, monitor recruitment barriers, and report progress to the principal investigator or management.
Oversee data entry and validation; create case report forms and data dictionaries in consultation with team members, the principal investigator, and statistician.
Support clinical research data management, address data queries, maintain and audit data, and provide status and activity reports.
Organize data to identify and report trends; review reports, tables, and listings; assist with data analysis and maintain study records and data storage.
Maintain master database files, prepare reports from validation studies, resolve report-content issues, and ensure timely, high-quality data submissions from study sites.
Oversee processing of laboratory and other external data.