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AMITA Health

Location: Elk Grove VillageIL 60007 Document ID: AD123-1MWR Posted on: 2019-05-2405/24/2019 Job Type: Regular

Job Schedule:Full-time
2019-06-23
 

Specialist-Research-Regulatory (Regulatory Administrator) - Alexian Brothers

We Are Hiring

Specialist-Research-Regulatory - Institutional Review Board 001 - Full-Time,Day - AMITA Health ABMC - Elk Grove Village,IL

Why Join AMITA?

AMITA Health (www.AMITAhealth.org) is a joint operating company formed by the Adventist Health System in Altamonte Springs, FL and St. Louis, MO based Ascension.

AMITA Health is the largest health system in Illinois, comprising 19 hospitals and more than 230 sites of care. The health system has 900 providers in its medical groups, more than 26,000 associates and 7,000 physician partners and serves over 4.3 million residents in the greater Chicagoland area.

What You Will Do

Specialist-Research-Regulatory (Regulatory Administrator)

Creates and submits all required regulatory submissions related to research studies conducted by the organization.

Responsibilities:

Coordinates, prepares, reviews, and submits required regulatory documentation.

Reviews and recommends changes to departmental policies, procedures and standards commensurate with regulatory developments.

Reviews and researches pertinent trends, issues, and developments in research and disseminates information to staff. Maintains regulatory references and materials.

Collaborates on the management of regulatory-related issues including serious adverse events and human subject participation.

Responsibilities
  • Initiates, administrates and maintains regulatory reporting and record keeping for clinical research and investigational treatment involving human subjects
  • Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOP's), and study specific protocols/plans and processes.
  • Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval.
  • Thorough knowledges of Good Clinical Practices, Code of Federal Regulations relating to clinical trials, and International Conference on Harmonization Guidelines, and Institutional and departmental research guidelines (e.g., IRB, research operational SOPs etc.)


What You Will Need

Licenses/Certifications/Registration:
  • Preferred Credential(s):
    • Research Professional.

Education:
  • Diploma
    • High school diploma/GED with 2 years of experience, or Associate's degree, or Bachelor's degree required

Regulatory Administrator

Responsibilities
  • Initiates, administrates and maintains regulatory reporting and record keeping for clinical research and investigational treatment involving human subjects
  • Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOP's), and study specific protocols/plans and processes.
  • Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval.
  • Thorough knowledges of Good Clinical Practices, Code of Federal Regulations relating to clinical trials, and International Conference on Harmonization Guidelines, and Institutional and departmental research guidelines (e.g., IRB, research operational SOPs etc.)

Position Requirements:
  • Bachelor degree preferred
  • A minimum of 3 years' experience in clinical research preferred
  • Knowledge of Good Clinical Practices, Code of Federal Regulations relating to clinical trials, and International Conference on Harmonization Guidelines.
  • Ability to understand medical terminology
  • Excellent communication skills
  • Excellent organizational skills
  • Working knowledge of computer applications
  • Ability to work independently
  • Able to be flexible with frequently changing priorities
  • Able to work with deadlines

Equal Employment Opportunity

AMITA Health will provide equal employment opportunities (EEO) to all associates and applicants for employment regardless of race, color, religion, national origin, gender, sexual orientation, gender identification or expression, age, disability, marital status, amnesty, genetic information, carrier status or any other legally protected status or status as a covered veteran in accordance with applicable federal, state and local laws.
 
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