Research Regulatory Coordinator

Posted 3 Days Ago
Be an Early Applicant
Centro, Maripí, Boyacá, COL
In-Office
Mid level
Healthtech
For the bumps, bruises and every curveball in between, go to Children's for that.
The Role
Coordinates regulatory activities for clinical research projects and trials, serving as a liaison to the Institutional Review Board and study sponsors. Responsibilities include preparing protocols, consent forms, lay summaries, amendments, renewals, regulatory reports, and audit materials; maintaining study personnel documentation; monitoring compliance with federal and institutional requirements; supporting enrollment and data reporting; and collaborating with faculty, staff, and leadership on ongoing research activities.
Summary Generated by Built In

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Work Shift

Day

Work Day(s)

Monday-Friday

Shift Start Time

8:00 AM

Shift End Time

4:30 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.

Children’s Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.

Primary Location Address

1575 Northeast Expy NE

Job Family

Research

Skills Required

  • Three years of research experience, or equivalent education beyond the minimum education requirement
  • Bachelor’s degree in a scientific, health-related, or business administration program, or relevant experience in lieu of education
  • Collaborative Institutional Training Initiative certification within 30 days of employment
  • Knowledge of federal regulations and regulatory requirements for conducting research
  • Medical terminology knowledge
  • Strong clerical accuracy, organization, communication, interpersonal, and independent judgment skills
  • Working knowledge of Microsoft Office, including Word, Excel, and PowerPoint
  • ACRP CRA or CCRC, SOCRA CCRP, or comparable certification within one year of employment or becoming eligible
  • Working knowledge of basic statistics
  • Regulatory experience

Children's Healthcare Of Atlanta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Children's Healthcare Of Atlanta and has not been reviewed or approved by Children's Healthcare Of Atlanta.

  • Healthcare Strength Comprehensive medical, dental, and vision coverage is paired with on‑site or near‑site primary care, a 24/7 nurse line, Teladoc, and counseling resources. Wellness services such as fitness centers, classes, and biometric screenings reinforce access to care and preventive support.
  • Parental & Family Support Near‑site child care, a child‑care credit, adoption and fertility assistance, and paid parental and other leaves indicate strong family‑oriented support. Everyday convenience perks like a free concierge service further ease caregiving and life logistics.
  • Retirement Support A dual‑plan setup with a 403(b) savings plan and a separate employer‑funded 401(a) growth plan signals meaningful long‑term financial support. Financial‑wellness resources are also highlighted.

Children's Healthcare Of Atlanta Insights

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The Company
HQ: Atlanta, Georgia
7,900 Employees
Year Founded: 1998

What We Do

For more than 100 years, Children’s Healthcare of Atlanta has depended on clinical and nonclinical employees to help make kids better today and healthier tomorrow. Consistently ranked as one of the leading pediatric healthcare systems in the country by U.S. News & World Report, Children’s is the only freestanding pediatric healthcare system in Georgia and one of the largest pediatric clinical care providers in the country. We’re also one of Atlanta’s leading employers and have been recognized as one of the nation’s top places to work. Our System includes: • 789 licensed beds • Three hospitals • Urgent Care Centers • Marcus Autism Center • Center for Advanced Pediatrics • Support Center for nonclinical staff • More than 14,000 employees, including more than 4,400 nurses and 2,300 physicians representing more than 60 pediatric specialties and programs Why Children’s? Here are some of the reasons new graduates and experienced clinicians alike choose Children’s. • We manage more than 1.1 million patient visits and 44,400 surgical procedures annually. • We are home to the only Level 1 and one of the only Level 2 pediatric trauma centers in Georgia. • We take a team approach to care. Our clinicians collaborate with social workers, chaplains, music therapists, therapy dogs and many others to help ensure kids receive comprehensive care.

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