Clinical Research Coordinator III - Clinical Research Services

Cincinnati Children's

3d•$56,784 - $63,960

About The Position

The Clinical Research Coordinator III supports the conduct and oversight of clinical research studies within Clinical Research Services. The role coordinates study activities, regulatory submissions and documentation, participant recruitment and retention, communications, and data management. The coordinator serves as a resource for clinical research professionals, collaborates with investigators and coworkers, and may communicate with sponsors and other organizations on behalf of the principal investigator.

Requirements

Bachelor's degree in a related field and at least 1 year of directly related experience, or a master's degree in a related field.
Knowledge of statistical process control principles.

Responsibilities

Maintain awareness of active study status and arrange study facilities and supplies.
Ensure participant and study compliance, including specimen collection and study visits; coordinate specimen procedures, train staff, and ensure specimens are properly logged, handled, processed, delivered, and stored according to study instructions.
Maintain records and files required by regulatory agencies and sponsors and serve as a resource for other clinical research professionals.
Collaborate with investigators and coworkers to support the progress and completion of clinical studies; train new staff in clinical trial preparation and conduct.
Prepare, submit, and maintain regulatory submissions, including new studies, annual reviews, amendments, and adverse events, accurately and on time.
Self-audit records, prepare for and participate in monitoring visits, audits, and quality reviews, and oversee protocol review, correspondence, approvals, and study closeout.
Identify additional regulatory review requirements and coordinate the steps needed to meet them; apply legal, regulatory, and policy requirements to promote ethical research and compliance.
Document regulatory activities, maintain accurate written and electronic records, and keep current on regulatory requirements. May communicate with sponsors, divisions, or institutions on behalf of the principal investigator.
Determine methods for identifying potential study participants, establish participant tracking systems, identify and screen potentially eligible participants, and monitor recruitment progress.
Conduct informed consent according to Good Clinical Practice (GCP), CCHMC procedures, and applicable rules and document participants approached, screened, and enrolled.
Communicate with participants’ clinical teams and study leadership about participation, recruitment challenges, and retention; recommend improvements and help address barriers.
Compose, organize, and maintain correspondence; follow through on study questions and issues and serve as a liaison to internal departments, clinical teams, regulatory agencies, physician offices, clinics, government agencies, academic centers, and other organizations.
Communicate study-related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers, and other institutions; develop rapport with study participants.
Create Case Report Forms (CRFs) as needed and complete CRFs and source documentation in accordance with applicable human research guidelines.
Review CRFs and source documents for completeness, accuracy, and Good Clinical Practice compliance; enter or oversee data entry and validation in auditable databases or electronic data-capture systems.
Perform data cleaning and quality checks; support data management, address data queries, review reports, tables, and listings, and assist with data analysis.
Maintain study master database files, records, and data storage, and prepare reports from clinical research project validation studies.