Clinical Trials Coordinator

Children’s Healthcare of Atlanta is hiring a Clinical Trials Coordinator to coordinate patient care and clinical research trials, including investigator-initiated and multicenter studies. The role oversees protocol conduct, data and safety monitoring, regulatory and administrative processes, data management, and training for participating sites and staff.

Responsibilities

Assists in the study design and implementation of new studies as requested/needed by the investigator

Develops, maintains, utilizes, and updates protocols, data collection tools, case report forms, spreadsheets, and databases for assigned studies

Ensures all reporting requirements are met at participating sites

Confirms patient eligibility from participating sites using eligibility checklists that are created for the project

Conducts site initiation visits (SIV), interim monitoring visits (IMV) and close out visits (COV) for multi-centered studies in compliance with protocol requirements

Maintains the agendas and minutes for the Data and Safety Monitoring Board including scheduling ad hoc meetings

Notifies the Data and Safety Monitoring Board chairperson of unexpected serious adverse drug reactions or serious adverse events

Submission to appropriate regulatory bodies as needed

Develops policies and procedures for the management of multi-centered studies

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

Serves as a resource for facilitating grants, contracts, and financial tasks for multi-centered clinical research projects

Oversees the maintenance of sites’ regulatory binders for purposes of Trial Master File (TMF) documentation

Point of contact for participating sites contracts and payment to sites for study start-up, patient enrollment, and other study needs

Works with study teams and investigators to ensure decisions are being met regarding amendments, dose escalation or de-escalation, suspensions/closures, and notification to regulatory agencies and sponsors

Creates and upkeeps lay and web summaries

Participates in the development of databases to use as the coordinating center

Develops and communicates project status reports and basic demographic and descriptive statistical information to multi-centered trials

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 including conducting Site initiation visits (SIV) and close out visits (COV)

Develops educational in-services for Children's Healthcare of Atlanta staff for assigned studies

Preferred

Master's degree in Business Administration, Healthcare Administration, or a scientific field

Experience in creating and negotiating study budgets and contracts

Experience in database development and management

Experience managing complex projects

Study Budget Development

Contract Negotiation

Database Development

Database Management

Complex Project Management

Company

Georgia pediatric healthcare system providing specialized care for children

Atlanta, Georgia, USA

http://www.choa.org/

Founded in 1997

10001+ employees

Qualifications

3 years of clinical experience with knowledge about the conduct of clinical studies/trials, research principles, and methodologies/study design

Bachelor's degree

Association of Clinical Research Professionals (ACRP), Certified Research Administrator (CRA) or Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professional (CCRP) within 1 year of hire

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

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

Master's degree in Business Administration, Healthcare Administration, or a scientific field

Experience in creating and negotiating study budgets and contracts

Experience in database development and management

Experience managing complex projects

Required skills

Clinical Research, Clinical Study Design and Methodology, Federal Research Regulations, ACRP Certification, Certified Research Administrator (CRA), Certified Clinical Research Coordinator (CCRC), SOCRA Certification, Certified Clinical Research Professional (CCRP), Collaborative Institutional Training Initiative (CITI), Study Budget and Contract Management, Database Development and Management, Complex Project Management

Preferred skills

Experience in database development and management, Experience managing complex projects, Glassdoor, 4.0, Atlanta, Georgia, USA, http://www.choa.org, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Represents job field similar to this job, Engineering and Development, Accounting and Finance, Education and Training, Customer Service and Support, Management and Executive, Trends of Total Sponsorships, *2026, (5), 2025, (2), 2024, (4), 2023, 2021, (1), Late Stage, Total Funding, $6.36M, Key Investors, Hyundai Hope On Wheels

Experience

3+ years