Research Administration Regulatory Analyst

JOB DESCRIPTION

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Work Shift

Work Day(s)

Monday-Friday

Shift Start Time

8 : 00 AM

Shift End Time

5 : 00 PM

Worker Sub-Type

Regular

Children’s is one of the nation’s leading children’s hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow.

We’re committed to putting you first, and that commitment is at the heart of our company culture : People first. Children always.

Find your next career opportunity and make a difference doing what you love at Children’s.

Job Description

Supports the efforts of investigators initiating clinical research studies by developing and submitting various regulatory and technical documents required in Food and Drug Administration (FDA) submissions, Institutional Review Board submissions, and other required documents for the initiation of these projects.

Drafts, reviews, edits, and finalizes documents by organizing, analyzing, and interpreting scientific and statistical data.

Also serves in a quality regulatory compliance role to support Children’s IRB and other internal research departments to ensure study conduct adheres to institutional policies, as well as state and federal regulations.

Experience

• Three years of experience in clinical research in a medical / behavioral setting, with knowledge about the conduct of clinical trials, research principles, and methodologies / study design.
• One years of experience developing, submitting, and executing clinical research projects.

Preferred Qualifications

Master’s degree in scientific or health-related field

Education

Bachelor’s degree in a scientific or health-related field or a bachelor’s degree in a non-scientific or health-related field with relevant experience.

Certification Summary

Collaborative Institutional Training Initiative (CITI) within 30 days of employment.

Knowledge, Skills and Abilities

• Strong writing skills with strong attention to detail.
• Demonstrated ability to manage timelines.
• Self-directed and motivated to work independently toward short- and long-term goals.
• Thorough understanding of documentation requirements related to IND and IDE submissions.
• Broad knowledge of federal regulations and regulatory requirements for conducting research.
• Working knowledge of information systems, including PC and Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, electronic IRB systems, CTMS, EMR, Electronic Data Capture (EDC) systems and associated databases.
• Demonstrated problem-solving, analytical, verbal, written communication, and presentation skills.
• Excellent customer service and verbal and written communication skills.

Job Responsibilities

• Prepare Investigative New Drug (IND) submission packets for the FDA that present clinical data objectively and in a clear, concise format.
• Collaborates with investigators for compassionate use needs.
• Assist study teams with developing informed consent documents for investigator-initiated protocols.
• Oversee INDs, eINDs, HUDs, etc. to ensure compliance and timely reporting.
• Manage a database of Pediatric Institute and Children’s held INDs / IDEs / HUDs.
• Collaborates with physicians to ensure accurate and timely submissions.
• Stays abreast of current industry practices and regulatory requirements and guideline.
• Provides guidance on federal and state regulations and guidelines, as well as institutional policy.
• Participates in quality and continuous improvement activities to ensure compliance in research.
• As directed, performs quality reviews as needed.
• Assists in any needs required for accreditation within Research at Children’s.

Primary Location Address

1575 Northeast Expy NE

Job Family

Research