Research Regulatory Coordinator RI Pulmonary Med

Nationwide Children's Hospital

Job Location:

Columbus, NE - USA

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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 CVs and licenses and confirms that IRB training requirements have been met. Maintains master file of current CVs 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

Required Experience:

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. Mainta...

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 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 CVs and licenses and confirms that IRB training requirements have been met. Maintains master file of current CVs 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

Additional Physical Requirements performed but not listed above:

(not specified)

Required Experience: