Cincinnati Children's Office of Academic Affairs and Career Development · 1 month ago
Clinical Research Coordinator II/III - DDBP - Esbensen Lab
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$27.30/hr - $29.88/hr
2+ years expCincinnati Children's Office of Academic Affairs and Career Development is seeking a dedicated Clinical Research Coordinator to support Dr. Anna Esbensen’s study focused on children and teens with Down syndrome. This patient-facing role involves administering cognitive assessments and collaborating closely with a team of experienced CRCs, ensuring compliance and effective communication throughout the research process.
Hospital & Health Care
Responsibilities
Maintain awareness of status of all active studies
Arrange for facilities and supplies
Ensure participant and study compliance, i.e. collection of study specimens, and study visits
Work with study team as needed to define specimen collection, processing and storage procedures
Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set
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 preparation and conduct of clinical trials
Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties
Periodically self-audit records to ensure audit-readiness
Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner
Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout
Determine which research protocols or issues have additional requirements, e.g. the need for review by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements
Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations
Document the conduct of each protocol's regulatory activities in appropriate systems
Maintain up-to-date & accurate written & electronic records & files to support clinical research activities
Continuously update knowledge of regulatory requirements
May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues
Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) 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
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 (tracking, electronic health, etc.) 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, 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 statistician, 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
Qualification
Required
High school diploma or equivalent, and 2 years of work experience in a related job discipline
Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field
Preferred
Bachelor's degree in a related field
Company
Cincinnati Children's Office of Academic Affairs and Career Development
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Cincinnati, Ohio, US
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase