Clinical Research Coordinator III - Mayerson Center

Cincinnati Children's

3d•$56,784 - $62,150•Onsite

About The Position

The Clinical Research Coordinator III plays a crucial role in the conduct of clinical research studies, ensuring compliance with all regulatory requirements and maintaining accurate documentation. This position involves managing study activities from initiation to closeout, including participant recruitment, enrollment, retention, data management, and regulatory submissions. The coordinator will serve as a key liaison between investigators, sponsors, regulatory agencies, and study participants, fostering ethical research practices and contributing to the advancement of medical discovery.

Requirements

Bachelor's degree in a related field AND 1+ years of directly related experience OR Master's degree in a related field

Responsibilities

Maintain awareness of the status of all active studies.
Arrange for facilities and supplies for studies.
Ensure participant and study compliance, including collection of study specimens and adherence to study visits.
Work with the study team to define specimen collection, processing, and storage procedures.
Train others on specimen collection, labeling, handling, and storage in accordance with protocols and SOPs.
Maintain all records and files required by regulatory agencies and sponsors.
Serve as a resource for other clinical research professionals in all aspects of conducting clinical trials.
Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies.
Train new staff in the preparation and conduct of clinical trials.
Prepare, submit, and maintain all regulatory submissions (new studies, annual reviews, amendments, adverse events) accurately and in a timely manner.
Periodically self-audit records to ensure audit-readiness.
Prepare, plan, and participate in monitor visits, audits, and quality reviews.
Oversee the review, correspondence, and approval of human research protocols with regulatory authorities, including study closeout.
Determine and coordinate the process for additional requirements for research protocols or issues.
Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants.
Document the conduct of each protocol's regulatory activities in appropriate systems.
Maintain up-to-date and accurate written and electronic records and files.
Continuously update knowledge of regulatory requirements.
Act on behalf of the PI in communicating with sponsors, other divisions, or institutions to coordinate studies.
Determine and prepare methods for identifying potential participants (advertisements, chart reviews, etc.).
Create and maintain a detailed tracking system for participants considered for enrollment.
Track progress at regular intervals and report to PI and/or management.
Identify potentially eligible participants and conduct pre-consent screening.
Review consent form with participant and provide time for consideration.
Execute the informed consent process according to GCP and CCHMC procedures.
Communicate with participants' clinical team regarding study participation.
Document participants approached, screened, and enrolled in applicable systems.
Communicate challenges with recruitment and retention to study leadership.
Make recommendations to improve recruitment and retention.
Engage study staff to assist in identifying and enrolling participants.
Proactively identify and monitor barriers to recruitment and problem-solve.
Compose, document, organize, and maintain all correspondence.
Oversee and follow through on questions and issues that arise during study conduct.
Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city 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 a rapport with study participants.
Create CRFs in consultation with team members for efficient data collection and entry.
Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines.
Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
Review documentation from sources to ensure accuracy.
Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation.
Perform data cleaning procedures and quality checks.
Support the data-management process, including addressing data queries.
Review reports, tables, and listings.
Assist in data analysis and maintain record keeping and data storage.
Maintain master database files for clinical research protocols.
Prepare reports from validation studies of clinical research projects.