Research Regulatory Coordinator

10 Children's Healthcare of Atlanta, Inc.; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Children’s Healthcare of Atlanta is seeking a regulatory research professional to support the approval process for clinical research projects and trials in the subspecialty area. You will liaise with the IRB, develop study protocols, and manage regulatory documentation to ensure compliance.

The role requires a Bachelor’s degree in a scientific/health-related field or equivalent experience, with 3 years of research experience and knowledge of regulatory requirements.

Qualifications

• High degree of clerical accuracy with attentiveness to detail
• Excellent written and verbal communication skills
• Ability to organize data and manage documentation

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, data collection sheets, spreadsheets, and databases for each research process.
• Develops consent forms compliant with federal and institutional guidelines to inform patients/guardians.
• Serves as site regulatory contact for sponsored projects.
• Maintains regulatory documents for study personnel (CVs, licenses, certifications).
• Develops lay summaries for protocols for IRB review.
• Collaborates to prepare documentation for initial review, renewals, amendments, and modifications; writes consents; reviews enrollment data and DSMR reports.
• Supports day-to-day regulatory reporting activities for patients on research protocols.
• Ensures compliance with organizational and regulatory standards; assists in policy development and audits.

Skills

Attention to detail

Communication skills

Independent work

Regulatory knowledge

Education

Bachelor’s degree in a scientific/health-related or business administration program

Tools

Microsoft Office

Regulatory databases

Job description

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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.

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

About the Organization

Children’s Healthcare of Atlanta has been 100 percent committed to kids for more than 100 years. A not-for-profit organization, Children’s is dedicated to making kids better today and healthier tomorrow. With 3 hospitals, 20 neighborhood locations and a total of 673 beds, Children’s is the largest healthcare provider for children in Georgia and one of the largest pediatric clinical care providers in the country. Children’s offers access to more than 60 pediatric specialties and programs and is ranked among the top children’s hospitals in the country by U.S. News & World Report. Children’s has been recognized as a Fortune 100 Best Place to Work, a Best Place for Working Mothers, and as a top employer for diversity and millennials.

Benefits

• We offer a comprehensive compensation and benefit package that supports our mission, vision and values.
• We are proud to offer an array of programs and services to our employees that have distinguished us as a best place to work in the country.
• Connect to our mission of making kids better today and healthier tomorrow.