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Work Shift
Day
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
Coordinates the care of patients and families enrolled in clinical research trials within accepted practices, policies, and philosophy of Children's Healthcare of Atlanta. Coordinates investigator-initiated and other clinical trials, including communication, regulatory, and research aspects. Summarizes study accrual, toxicities, and other data to ensure appropriate documentation onsite and by participating outside institutions. Acts as liaison between the Data and Safety Monitoring Board and Principal Investigators to ensure that studies are regulated and reviewed appropriately for the program. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.
Experience

• 3 years of clinical experience with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
• 2 years of experience in managing complex projects

Preferred Qualifications

• Master's degree in Business Administration, Healthcare Administration, or a scientific field
• Experience in creating and negotiating study budgets and contracts

Education

• Bachelor's degree in a scientific or health-related field

Certification Summary

• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
• Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Knowledge, Skills, and Abilities

• Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
• Self-directed and motivated to work independently toward short- and long-term goals
• Good communication, organization, and interpersonal skills

Job Responsibilities

• Provides leadership and training for all multi-centered clinical research activities.
• Trains participating sites on all activities related to the research project such as eligibility criteria, enrollment instructions, reporting requirements, and monitoring plans.
• Completes regulatory site accreditation and audit process of participating sites.
• Oversees participating institutions to ensure that research and protocol activities comply with organizational guidelines and regulatory standards for multi-centered studies.
• Develops policies and procedures for the management of multi-centered studies.
• Develops educational in-services for multi-centered trials.
• Ensures all reporting requirements are met at participating sites.
• Serves as a resource for facilitating grants, contracts, and financial tasks for multi-centered clinical research projects.
• Oversees the maintenance of sites' regulatory binders.
• Oversees the contracts for participating sites and payment to sites for study start-up, patient enrollment, and other study needs.
• Assists in the study design and implementation of new studies.
• Provides training and assistance for research protocol development and conduct.
• Participates in the development of databases to use as the coordinating center.
• Assists in the development of protocols and case report forms.
• Confirms patient eligibility from participating sites.
• Develops and communicates project status reports and basic demographic and descriptive statistical information to multi-centered trials.
• Provides leadership for data and safety monitoring.
• Works with study teams to ensure decisions are being met regarding amendments, dose escalation or de-escalation, suspensions/closures, and notification to regulatory agencies and sponsors.
• Requests unscheduled meetings of the Data and Safety Monitoring Board when unforeseen circumstances arise.
• Notifies the Data and Safety Monitoring Board chairperson of unexpected serious adverse drug reactions or serious adverse events.
• Provides coordination of research studies as needed.
• Creates and upkeeps lay and web summaries and develops eligibility checklists and specimen summary sheets for assigned studies.
• Develops study documents for assigned studies based on protocol and study process.
• Develops educational in-services for Children's Healthcare of Atlanta staff for assigned studies.
• Develops, maintains, utilizes, and updates protocols, data collection tools, spreadsheets, and databases for assigned studies.

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