Research Regulatory Coordinator

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

Develops, implements, and supports the regulatory research process by assisting investigators in completion of the regulatory approval process for external and internal clinical research projects and clinical trials specific to the subspecialty of involvement.

Functions as a liaison for the Institutional Review Board and study sponsors.

Experience

Three (3) years of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement

Preferred Qualifications

• Association of Clinical Research Professionals (ACRP), Certified Research Associate (CRA) or Certified Clinical Research Coordinator (CCRC) OR Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professional (CCRP) OR comparable within 1 year of employment or 1 year of becoming eligible
• Working knowledge of basic statistics
• Regulatory Experience

Education

Bachelor’s degree in a scientific, health related, or business administration related program or relevant experience in lieu of education.

Certification Summary

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

Knowledge, Skills, and Abilities

• Must demonstrate a high degree of clerical accuracy with attentiveness to detail and ability to organize data
• Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to provide education and training
• Knowledge of medical terminology
• Self-directed and motivated to work independently toward short- and long-term goals and the ability to exercise independent judgment
• Effective communication, organization, and interpersonal skills
• Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Excel, and PowerPoint)

Job Responsibilities

• Manages departmental regulatory aspects for clinical trial and research activities.
• Serves as the Institutional Review Board liaison for all regulatory activities within the department.
• Develops, maintains, utilizes, and updates protocols as needed, and data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
• Develops written consent / assent forms for each protocol which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions.
• Serves as the site regulatory contact for sponsored projects
• Maintains regulatory documents for all study personnel, including, but not limited to, curriculum vitae, licenses, certifications and bio-sketches, Develops lay summaries for each protocol which are utilized by the Institutional Review Board in the initial review process.
• Collaborates with departmental staff and faculty to develop and complete necessary documentation for initial study review, continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports.
• Supports the Research Managers in the day-to-day activities of regulatory reporting for patients enrolled on research protocols.
• Collaborates with all departments to ensure research complies with organizational guidelines and regulatory standards.
• Assists in formulating departmental policies and guidelines.
• Assists in preparation for audits and inspections as needed.
• Provides reporting of all regulatory activities to department leadership as requested.
• Works collaboratively with faculty and staff on all initial and ongoing protocols, amendments, and Institutional Review Board re-approvals in accordance with IRB-mandated policies and timelines.

Primary Location Address

1575 Northeast Expy NE

Job Family

Research