Clinical Research Coordinator II/III - Hospital Medicine

Cincinnati Children's•Orleans, MA

4d•$56,784 - $62,150•Onsite

About The Position

This role is responsible for the conduct of clinical research studies, ensuring compliance with all regulatory requirements and institutional policies. The Clinical Research Coordinator will manage study activities from initiation to closeout, including participant recruitment, data management, and regulatory documentation. This position serves as a key liaison between investigators, sponsors, regulatory agencies, and study participants, contributing to the advancement of medical science and patient care within Hospital Medicine.

Requirements

Required for CRC II: High school diploma or equivalent, and 2 years of work experience in a related job discipline.
Required for CRC III: Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field.

Nice To Haves

Preferred for CRC II: Bachelor's degree in a related field.

Responsibilities

Maintain awareness of the status of all active studies, arranging for facilities and supplies.
Ensure participant and study compliance, including collection, processing, and storage of study specimens according to protocol and SOPs.
Train staff on sample collection, labeling, processing, and storage procedures.
Maintain all records and files required by regulatory agencies and sponsors.
Serve as a resource for other clinical research professionals in all aspects of clinical trial conduct.
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 all monitor visits, audits, and quality reviews (internal & external).
Oversee the review, correspondence, and approval of human research protocols with all regulatory authorities, including study closeout.
Determine and coordinate the process for research protocols or issues requiring review by additional divisions, regulatory agencies, or consultants.
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 to support clinical research activities.
Continuously update knowledge of regulatory requirements.
Act on behalf of the PI in communicating with sponsors, other divisions, or institutions to coordinate studies and follow through on issues.
Determine and implement methods to identify potential participants for research protocols (advertisements, chart reviews, clinic schedule monitoring).
Create and maintain a detailed tracking system for participants considered for enrollment.
Track participant progress, report to PI and/or management, identify potentially eligible participants, and conduct pre-consent screening.
Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations, and policies.
Communicate with participants' clinical team regarding study participation.
Document participant interactions (approached, screened, enrolled) in applicable systems.
Communicate challenges with recruitment and retention to study leadership and make recommendations for improvement.
Engage study staff to assist in identifying and enrolling participants.
Proactively identify and monitor barriers to recruitment and problem-solve to overcome them.
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 for human research.
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 to ensure data accuracy.
Support the data-management process, including addressing data queries from data managers, project statisticians, and sponsors.
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.