Senior Clinical Research Coordinator—Regulatory & Data Lead

CO00 Children's Hospital Medical Center; United States; On-site; USD 57,000 - 64,000; Full time

Job summary

Cincinnati Children’s is seeking a Clinical Research Coordinator to support study conduct and regulatory compliance across multiple trials at the Burnet Campus. The role involves coordinating participants, ensuring protocol adherence, and maintaining intricate regulatory documentation.

The successful candidate will hold a related degree (Bachelor’s with experience or Master’s) and have knowledge of regulatory requirements and data management.

Qualifications

• Bachelor's degree in a related field with 1+ years of directly related experience OR Master's degree in a related field
• Knowledge of statistical process control principles

Responsibilities

• Study conduct/clinical research: maintain awareness of active studies; arrange facilities; ensure participant and study compliance; train staff on collection and labeling of samples; log, handle and store specimens; maintain records for regulators and sponsors; collaborate with investigators; train staff.
• Regulatory compliance and documentation: prepare/submit/regulatory submissions; audit records; participate in monitor visits/audits; ensure compliance to regulations; document regulatory activities; maintain accurate records.
• Recruitment/enrollment/retention: identify potential participants; maintain tracking system; screen and obtain informed consent; communicate with clinical teams; document engagement and enrollment; address barriers to recruitment.
• Communication: compose and organize all correspondence; liaise with internal/external stakeholders; develop rapport with study participants.
• Data management: create CRFs; ensure accuracy and completeness; data entry and validation; perform data cleaning; support data-management processes; prepare reports.

Skills

Clinical research

Education

Bachelor's degree in a related field

Master's degree in a related field

Job description

Cincinnati Children’s is seeking a Clinical Research Coordinator to support study conduct and regulatory compliance across multiple trials at the Burnet Campus. The role involves coordinating participants, ensuring protocol adherence, and maintaining intricate regulatory documentation.

The successful candidate will hold a related degree (Bachelor’s with experience or Master’s) and have knowledge of regulatory requirements and data management.