About this role
Overview:
Job Description Summary:
Job Description:
- Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
- Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
- Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
- Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
- Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
- Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,
- Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
- Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
- Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
- Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
- Assists the principal investigator in the preparation of scientific publications and grant proposals.
Education Requirement:
- Associate's degree or equivalent work-related experience, required.
- BA/BS, preferred.
Licensure Requirement:
(not specified)
Certifications:
CRA/CRC certification, preferred.
Skills:
- Understanding of medical terminology and clinical trials preferred.
- Working knowledge of PCs and word processing and data management software.
- Demonstrated analytical skills with accuracy and attention to detail.
- Excellent verbal and written communication skills.
- Goal-oriented and self-directive, ability to manage complex projects independently.
- Strong organizational and interpersonal skills.
- Ability to actively participate as a team player.
Experience:
Eighteen months experience in clinical research or health care field, required.
Physical Requirements:
OCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel
FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking
CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near
Additional Physical Requirements performed but not listed above:
(not specified)
"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"
Other facts
About Nationwide Children's Hospital
Nationwide Children’s is one of America's largest pediatric hospitals, an international leader in research and is ranked in all 10 specialties on U.S. News & World Report’s 2025-26 “America’s Best Children’s Hospitals” list. Our staff, comprised of 1,600 medical professionals and over 16,000 employees, provides state-of-the-art pediatric care for 1.8 million patient visits annually. And, according to the Children’s Hospital Association, Nationwide Children's is the #1 provider of pediatric surgery in the country.
Our doctors represent every major pediatric sub-specialty. With over 50 locations throughout Ohio, signature programs include heart, cancer, gastroenterology and neonatology care, all of which are internationally recognized. Tim Robinson is CEO of Nationwide Children’s Hospital, which includes the Abigail Wexner Research Institute at Nationwide Children’s Hospital, Nationwide Children’s Hospital Foundation and The Center for Family Safety and Healing at Nationwide Children’s Hospital.
As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. Nationwide Children’s remains true to the original mission since its founding in 1892 of providing care regardless of a family’s ability to pay. More information is available at NationwideChildrens.org.
What you'll do
- The Clinical Research Coordinator II manages various elements of clinical studies, ensuring adherence to protocols and safety standards. This includes recruiting and enrolling subjects, coordinating study visits, and managing data collection.
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