Clinical Research Coordinator III/IV - Allergy Department

Cincinnati Children's

5d•$56,784 - $78,291

About The Position

The Clinical Research Coordinator III/IV in the Allergy Department supports complex and multi-center clinical trials. The role provides guidance and resources to research staff, trains new staff, may directly or indirectly supervise other coordinators, and collaborates with investigators and other teams to keep studies progressing and completed appropriately. Responsibilities also include collecting and processing specimens and coordinating their handling, storage, and tracking. The coordinator oversees complex regulatory activities and documentation, including submissions, protocol review and closeout, internal audits, monitor visits, external audits, and quality reviews. The position applies relevant federal, state, and local regulations and institutional policies to support ethical research and compliance, and maintains accurate written and electronic records. The role prepares study teams for recruitment and enrollment, monitors recruitment progress and barriers, develops approaches to identify potential participants, and tracks enrollment activity for reporting to investigators or management. It also oversees data entry, validation, quality, and compliance; supports data queries; maintains study databases and records; organizes and reviews data and reports; and oversees processing of laboratory and other external data.

Requirements

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 with 3 years of experience in a related job discipline, or a Master's degree with 2 years of experience in a related job discipline.
Obtain Certified Clinical Research Coordinator certification within 18 months of external hire date.

Responsibilities

Serve as a resource for conducting complex and multi-center clinical trials and develop and implement related projects under the principal investigator's guidance.
Collaborate with others to support study progress and completion, and assist staff through education, resources, and consultation on protocols and projects.
Train new staff and provide oversight and guidance to research staff; directly or indirectly supervise other clinical research coordinators.
Collect and process specimens and coordinate their handling, processing, storage, and tracking with other divisions.
Coordinate complex regulatory activities and periodic internal self-audits; provide oversight for regulatory preparation, review, submission, and maintenance.
Coordinate and participate in monitor visits, audits, and internal and external quality reviews.
Organize protocol review, correspondence, approvals, and study closeout with relevant regulatory authorities; identify and coordinate any additional review requirements.
Apply federal regulations, state and local laws, and institutional and divisional policies and procedures to support ethical research and regulatory compliance.
Maintain current, accurate written and electronic regulatory records and files.
Prepare study staff for recruitment and enrollment, oversee their performance, and take initiative to keep recruitment on schedule.
Identify potential participants, develop and maintain participant tracking systems, monitor recruitment barriers, and report progress to the principal investigator or management.
Oversee data entry and validation to ensure accuracy, quality, and compliance with the data-collection process.
Develop case report forms and data dictionaries in consultation with team members, the principal investigator, and statistician as appropriate.
Support clinical research data management, including responding to data queries and maintaining and auditing data.
Organize data to identify and report trends; review reports, tables, and listings; assist with data analysis; and maintain study records, storage, and master database files.
Prepare reports from validation studies, resolve report-content issues, and ensure timely submission and quality of data from study sites.
Oversee processing of laboratory and other external data.