Clinical Research Coordinator II/III - Neurology (Headache Study)

Cincinnati Children's

3d•Onsite

About The Position

This role involves managing and conducting clinical research studies, specifically focusing on a Headache Study within the Neurology department. The position requires a strong understanding of clinical research practices, regulatory compliance, participant recruitment and retention, data management, and effective communication with various stakeholders. The Clinical Research Coordinator will be responsible for ensuring studies are conducted according to protocols, maintaining accurate records, and collaborating with investigators and study teams to achieve study goals.

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, arrange for facilities and supplies.
Ensure participant and study compliance, including collection of study specimens and adherence to study visits.
Define specimen collection, processing, and storage procedures, and train others as needed.
Ensure specimens are properly logged, handled, and stored.
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 a clinical trial.
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 (proposed new studies, annual reviews, amendments, and adverse events) accurately and within a timely manner.
Periodically self-audit records to ensure audit-readiness.
Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) in a professional manner.
Oversee the review, correspondence, and approval of human research protocols with all regulatory authorities, including study closeout.
Determine which research protocols or issues have additional requirements and coordinate the process to meet these requirements.
Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants and to ensure compliance.
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 the best method(s) to identify potential participants for research protocols and prepare accordingly.
Create and maintain a detailed tracking system for participants considered for enrollment.
Track progress at regular intervals and report out to PI and/or management.
Identify potentially eligible participants and conduct pre-consent screening to determine eligibility.
Review consent form with participant and provide time for participant to consider study participation.
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 in applicable systems participants approached, screened, and enrolled in the study.
Communicate challenges with recruitment and retention to the study leadership.
Make recommendations to improve recruitment and retention to the study leadership.
Engage study staff to assist in identifying and enrolling participants.
Proactively identify and monitor barriers to recruitment and problem-solve or innovate 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 other team members, as needed, using existing study data information to promote efficient data collection and data 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 to ensure accuracy and completeness of data collection process.
Perform data cleaning procedures and quality checks to ensure accuracy of data.
Support the data-management process for clinical research projects, 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.