Research Regulatory Coordinator - RI Pulmonary Med

nationwidechildrens· 10 Nationwide Children's Hospital
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Full time10 Nationwide Children's Hospital

About this role

Overview:


 


 

Job Description Summary:


 

Assists with the administrative components required to ensure compliance in the regulatory processes for a clinical research project.


 

Job Description:


 

Essential Functions:

  • Creates the initial study administrative binder required for the clinical research project. Maintains study binders, files documents timely, and reviews binders prior to monitor visits to ensure completeness.
  • Prepares, submits, and maintains IRB related documents.Ensures accuracy and congruency between IRB, regulatory documents, study documents and grants system.
  • Confirm all investigators, staff and departments to be used for the study. Collects CV’s and licenses and confirms that IRB training requirements have been met. Maintains master file of current CV’s and licenses.
  • Collects and stores regulatory documents required by the clinical research project in compliance with federal and local regulations and guidelines.
  • Keeps site documents up to date (IRB roster, lab certificates, etc.). Oversees document retrieval and archival process at study termination.
  • Works with marketing and research staff to ensure studies utilizing recruitment tactics are posted appropriately.


Education Requirement:

Associates degree or equivalent experience in medical/science field.


Licensure Requirement:

(not specified)


Certifications:

(not specified)


Skills:

Strong administrative skills and attention to detail.

Excellent computer skills.

Knowledge of medical terminology and diseases.

Ability to multi-task; customer focused personality with strong organizational and prioritization skills.

Working knowledge of IRB and regulatory processes and systems.

Current knowledge of Federal regulations (FDA, GCP, NIH, DHHS, ICH GCP), and study protocols.


Experience:

Six months research experience, preferred.


Physical Requirements:

OCCASIONALLY: Bend/twist, Driving motor vehicles (work required) *additional testing may be required, Reaching above shoulder, Squat/kneel

FREQUENTLY: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 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"

Frequently Asked Questions

Is the salary disclosed for the Research Regulatory Coordinator - RI Pulmonary Med position at nationwidechildrens?
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Where is the Research Regulatory Coordinator - RI Pulmonary Med position at nationwidechildrens located?
This Research Regulatory Coordinator - RI Pulmonary Med role at nationwidechildrens is based in Main Campus, Columbus, OH. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Research Regulatory Coordinator - RI Pulmonary Med role at nationwidechildrens full-time or part-time?
This is listed as a Full time position. It is posted as a Research Regulatory Coordinator - RI Pulmonary Med role in the 10 Nationwide Children's Hospital department at nationwidechildrens.
Which team or department does the Research Regulatory Coordinator - RI Pulmonary Med at nationwidechildrens belong to?
This Research Regulatory Coordinator - RI Pulmonary Med position is part of the 10 Nationwide Children's Hospital department at nationwidechildrens. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Research Regulatory Coordinator - RI Pulmonary Med position at nationwidechildrens?
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Research Regulatory Coordinator - RI Pulmonary Med
nationwidechildrens
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