Clinical Research Coordinator IV-School of Medicine, Georgia CTSA

KEY RESPONSIBILITIES

• Recruits, orients, and supervises research administration staff or independently manages the most complex research administration activities associated with the conduct of clinical trials.
• Manages a large or multiple smaller clinical research projects.
• Manages clinical trials related information systems.
• Supervises the implementation of and adherence to study protocols.
• Makes sure expenditures and adherence to study budgets are correct and resolves CAS issues.
• Teaches research staff about established policies, processes, and procedures.
• Determines effective ways to encourage/recruit research participants and keep participants in long-term clinical trials.
• Periodically checks operations including laboratory procedures to make sure they comply with applicable regulations; provides leadership in identifying and carrying out corrective actions/processes.
• Plans, identifies, and handles study-related equipment and facility needs.
• Provides leadership and expertise in identifying and completing research grants, study materials, brochures, and correspondence.
• Develops and submits grant proposals.
• Led or chaired committees or task forces to address and resolve significant issues.
• Performs related approved responsibilities as required.

MINIMUM QUALIFICATIONS

• A high school diploma or GED and nine years of clinical research experience.
• Two years of college in a scientific, health-related, or business administration program and seven years clinical research experience.
• A licensed Practical Nurse (LPN) and six years clinical research experience.
• A bachelor's degree in a scientific, health-related, or business administration program and five years of clinical research experience.
• A master's degree, MD, or PhD in a scientific, health-related, or business administration program and two years of clinical research experience.
• A certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.

PREFERRED QUALIFICATIONS

• Six or more years of clinical research coordination experience, preferably in an academic medical center.
• Experience managing complex interventional clinical trials.
• Strong knowledge of Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) guidelines, and Health Insurance Portability and Accountability Act (HIPAA).
• Experience with Institutional Review Board (IRB) submissions, informed consent, regulatory files, and monitoring visits.
• Proficiency with OnCore, REDCap, Epic, and Electronic Data Capture (EDC) systems.
• Ability to manage multiple studies and priorities independently.
• Experience training or mentoring junior Clinical Research Coordinators (CRCs).
• Excellent organizational, communication, and problem-solving skills.
• Experience with inpatient, device, biologic, oncology, transplant, or critical care studies preferred.

Additional Details

This position supports clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory University is an equal opportunity employer, and qualified individuals will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristics protected by state or federal law. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran’s Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). For inquiries regarding this policy, please contact the Emory University Department of Equity and Civil Rights Compliance at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD).