Clinical Research Coordinator lll or lV Neonatology -follow up Assessment
Cincinnati Children's Hospital Medical Center

Job Description

At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic 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.

Cincinnati Children's Hospital Has Been Named:

• Consistently recognized by U.S. News & World Report as a top 10 children's hospital in the nation
• One of four Medical Centers making the list of the 2022 Glassdoor Best Places to Work
• A Top Hospital and Health System for Diversity recognized by DiversityInc
• One of the nation's most innovative companies by Fortune in March 2023
• An LGBTQ+ Healthcare Equality Top Performer in 2022 by The Human Rights Campaign (HRC)

JOB RESPONSIBILITIES

Follow-Up Assessment Specialist (Research Coordinator III or IV) - Division of Neonatology

Cincinnati Children's Hospital is seeking a Clinical Research Coordinator III or IV to join our Division of Neonatology & Pulmonary Biology. The Division of Neonatology has played an important role in performing clinical trials in neonates by participating as one of the 15 sites for the NICHD Neonatal Research Network, which has been internationally recognized for findings that have led to significant advances in the clinical care of newborn infants.

Many research studies conducted in the NICU include developmental follow-up with participants when they are 2-5 years old. In this role, the Clinical Research Coordinator will be specialized in conducting a battery of neurodevelopmental assessments, including certification in performing the Bayley Scales of Infant Development and the Differential Abilities Scale-II. The assessments are completed on infants and young children in our research follow-up clinic. The Clinical Research Coordinator will ensure quality, human subject safety and data integrity of clinical trials conducted within the Division. The individual will work with the investigators to manage the research studies including participant recruitment, enrollment and retention, scheduling, conducting study visits, data management, regulatory compliance and documentation.

• 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.
  
• Recruitment/Enrollment/Retention - 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.
  
• Communication - 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.
  
• Data Management - 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.
  

JOB QUALIFICATIONS

• Bachelor's degree in a related field
  
• 1+ years of directly related experience OR Master's degree in a related field
  
• Knowledge of statistical process control principles
  

Market Leading Benefits Including*:

• Shift Differential, Weekend Differential, and Weekend Option Pay Programs
• Medical coverage starting day 1 of employment. View employee benefits here.
• Competitive retirement plans
• Tuition reimbursement for continuing education
• Expansive employee discount programs through our many community partners
• Referral bonus program for current staff!
• Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQIA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group
• Physical and mental health wellness programs
• Relocation assistance available for some positions

*Benefits may vary based on FTE Status and Position Type

Primary Location
Location T

Schedule
Full time

Shift
Day (United States of America)

Department
Neonate & Pul Biol

Employee Status
Regular

FTE
1

Weekly Hours
40

Comprehensive job description provided upon request.

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability.

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