Cincinnati Children's Office of Academic Affairs and Career Development · 16 hours ago
Clinical Research Coordinator III/IV - Allergy Department - Assa'ad Lab
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$57K/yr - $62K/yr
1+ years expCincinnati Children's Office of Academic Affairs and Career Development is seeking a Clinical Research Coordinator in the Assa’ad Lab to support clinical and translational studies focused on food allergies and atopy. The role involves conducting clinical trials, ensuring regulatory compliance, overseeing recruitment and data management, and collaborating with diverse patient populations.
Hospital & Health Care
Responsibilities
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
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 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
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
Qualification
Required
Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field
Bachelor's degree in a related field with 3 years of experience in related job discipline or Master's degree and 2 years of experience in a related job discipline
Certified Clinical Research Coordinator within 18 months of external hire date
Company
Cincinnati Children's Office of Academic Affairs and Career Development
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Cincinnati, Ohio, US
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase