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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 studies/ trials, research principles, and methodologies/study design
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 Education Bachelor’s degree Certification Summary 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 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
Develops and oversees conduct of research protocols 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 Provides oversight for data and safety monitoring 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. Manages regulatory and administrative processes related to clinical research activities for multi-centered trials 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 Completes data management activities 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. Performs quality and education activities 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. 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