Clinical Research Coordinator III - Anesthesia

Cincinnati Children's

3d•$56,784 - $63,960•Onsite

About The Position

The Clinical Research Coordinator III in the Anesthesia Department conducts and coordinates clinical research studies, including study operations, regulatory compliance, participant recruitment and retention, communication, and data management. The coordinator maintains study records and specimens, supports protocol and regulatory processes, helps ensure ethical and compliant research practices, and collaborates with investigators, study teams, participants, sponsors, and other organizations. The role also serves as a resource to clinical research professionals and may train new staff.

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 studies and arrange required facilities and supplies.
Ensure participant and study compliance, including specimen collection and study visits; coordinate specimen procedures, training, logging, handling, processing, delivery, and storage.
Maintain records and files required by regulatory agencies and sponsors, and serve as a resource to other clinical research professionals.
Collaborate with investigators and coworkers to support the progress and completion of clinical studies; train new staff in trial preparation and conduct.
Prepare, submit, and maintain regulatory submissions, including new studies, annual reviews, amendments, adverse events, and study closeouts.
Self-audit records and prepare for, plan, and participate in monitoring visits, audits, and quality reviews.
Coordinate protocol review and approval with regulatory authorities and additional divisions, agencies, or consultants as needed.
Apply legal, regulatory, and policy requirements to support ethical research and compliance; document regulatory activities and maintain accurate records.
Maintain current knowledge of regulatory requirements and, when needed, communicate on behalf of the PI with sponsors, divisions, or institutions.
Identify potential participants, establish tracking systems, screen for eligibility, conduct informed-consent discussions, and document participants approached, screened, and enrolled.
Track recruitment and retention, report progress and challenges, recommend improvements, engage study staff, and address barriers to enrollment.
Compose and maintain correspondence; follow through on study questions and issues; serve as a liaison among internal departments, clinical teams, regulatory agencies, and external organizations.
Communicate study-related issues to investigators, sponsors, coordinating centers, study teams, managers, and other institutions, and develop rapport with participants.
Create and complete case report forms and source documentation; review records for accuracy, completeness, 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, resolve data queries, review reports, tables, and listings, assist with data analysis, and maintain study databases, records, and data storage.
Prepare reports from validation studies of clinical research projects.