Senior Research Regulatory Coordinator - Research Translational
Company: Nationwide Children's Hospital
Posted on: September 24, 2022
Research Regulatory Coord Senior - Research TranslationalThe
Senior Research Regulatory Coordinator plays an integral role in
the regulatory/compliance process of all clinical research
conducted in the NCH/RI system. This process includes human
subjects research project submissions to the Institutional Review
Board (IRB), submission of Investigational New Drug Applications
(IND?s) to the U.S. Food and Drug Administration (FDA), overseeing
the preparation & submission of regulatory/compliance documents to
study sponsors and assistance with quality improvement initiatives.
The position requires a working knowledge of federal regulations
including FDA, National Institute of Health (NIH), Department
Health and Human Services (DHHS); International Conference on
Harmonization Good Clinical Practices (ICH GCP), study protocols
and IRB policy, as well as an understanding of the day to day
clinical research process.The moment you walk through our doors,
you feel it. When you meet our patient families, you believe it.
And when you talk with anyone who works here, you want to be part
of it. Welcome to Nationwide Childrens Hospital, Where Passion
Meets Purpose.Here, Diversity, Equity and Inclusion are integrated
into our core values and practices. We are passionate about
building, sustaining and evolving an inclusive and equitable
environment. We are seeking individuals who live these values and
want to share their experiences and efforts in support of our
collective mission. Were 14,000 strong. And it takes every one of
us to improve the lives of the kids we care for, and the kids
around the world well never meet. Kids who live healthier, fuller
lives because of the knowledge we share. We know it takes a
Collaborative Culture to deliver on our promise to provide the very
best, innovative care and to foster new discoveries, made possible
by the most groundbreaking research. Anywhere.Ask anyone with a
Nationwide Childrens badge what they do for a living. Theyll tell
you its More Than a Job. Its a calling. Its a chance to use and
grow your talent to make an impact that truly matters. Because
here, we exist simply to help children everywhere.Nationwide
Childrens Hospital. A Place to Be Proud.PRINCIPAL DUTIES AND
- Reviews study protocols in order to write consent/assent
documents and develop the initial IRB submission; submits protocol
amendments; responds to contingencies and obtains final approval of
documents from sponsor and IRB, on behalf of principal
- Serves as liaison between study sponsors and the research team
(IRB, research staff and Principal Investigator) regarding
regulatory matters in the IRB submission and approval process.
- Responsible for the preparation, submission and maintenance of
documents and processes related to investigator-initiated
- Serves as liaison with federal agencies as needed.
- Oversees the creation and maintenance of regulatory documents
and the study administrative binder required for the clinical
- Maintains current knowledge of federal research regulations by
reviewing current publications and attending conferences.
- Advises management of regulation changes and projected impact
within Clinical Research Services and the institution.
- Primary resource to provide guidance to investigators and
research staff on federal regulations, good clinical practices and
IRB policies and systems.
- Identifies protocol content which may conflict with federal
and/or local requirements or practice.
- Assists with quality improvement audits, including the
administrative binder, subject research records, case report forms
and other study documents.
- Responsible for data required for CCTS annual report and other
metrics as required.KNOWLEDGE, SKILLS AND ABILITIES
- Bachelor's degree or equivalent experience in medical/science
- CCRP certification preferred.Skills and experience:
- Knowledge of medical terminology and diseases preferred.
- Excellent computer skills.
- Ability to multi-task with strong organizational and
- Strong attention to detail. ? Customer focused
- Clinical Research Experience (minimum of 2 years, 5 years
preferred)Working knowledge of IRB and regulatory processes and
- Current knowledge of Federal regulations including Food and
Drug Administration (FDA), Good Clinical Practice (GCP), National
Institute of Health (NIH), Department of Health and Human Services
(DHHS); International Conference on Harmonization Good Clinical
Practice (ICH GCP) and study protocols.MINIMUM PHYSICAL
- 1-33% OF TIME (0.5 TO 2.5 HOURS)Bend/twist
- Reaching above shoulder
- Driving FREQUENTLY 34-66% OF TIME (2.6 TO 5.0 HOURS)
- Lifting/carrying up to 30 lbs.Pushing/pulling up to 50 lbs. may
need assistance CONTINUOUSLY 67-100% OF TIME (5.1 TO 12 HOURS OR
- Flexing/extending of neck
- Hand use: grasping, gripping, turning
- Repetitive hand/arm use
- Computer skills Audible speech
- Hearing acuity
- Depth perception
- Peripheral vision
- Seeing-far/near Problem solving
- Decision making Interpreting data
- The above list of duties is intended to describe the general
nature and level of work performed by individuals assigned to this
classification. EOE M/F/Disability/VetRequisition ID: 2022-36261
External Company Name: Nationwide Children's Hospital External
700 Children's Dr
Keywords: Nationwide Children's Hospital, Columbus , Senior Research Regulatory Coordinator - Research Translational, Other , Columbus, Ohio
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