SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.
Study Conduct/ Clinical Research Practice
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.
Regulatory Compliance and Documentation
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.
Bachelor's degree in a related field
1 year of directly related experience OR Master's degree in a related field
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better, and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.