JOB DESCRIPTION: ***This is a central job, reporting to the Office for Clinical Research (OCR).*** Reviews Clinical Trial and Applicable Clinical Trial Determination Criteria for studies to ensure compliance with FDA, ICMJE, NIH, and Emory University policies and guidelines for ClinicalTrials.gov on behalf of Emory University. Provides guidance to Emory investigators and other internal regulatory entities for clinical trial (FDA, NIH, etc.) determinations, as well as Sponsor identification. Participates in national ClinicalTrials.gov Taskforce Committee and discussions, as well as national working groups with the NIH (e.g., modernization efforts), as necessary. Verifies grant numbers and collaborates with investigators as they resolve inconsistencies between ClinicalTrials.gov and any NIH progress report warnings or other NIH grant questions that arise in relation to public posting of ClinicalTrials.gov registration and/or results reporting.
Has responsibility for the thorough review of complex study protocols and Informed Consent Documents (ICDs) to register and update study records in ClinicalTrials.gov as applicable, as well as identify any EHC and/or Grady billable items and services required of the study which might generate a CPT code that requires a Prospective Reimbursement Analysis (PRA) to ensure research billing compliance.
Facilitates and manages ClinicalTrials.gov activities associated with Emory-sponsored and investigator-initiated research studies. Ensures timely registration, updates, amendment revisions, NIH QA review comment responses and proficiency with results reporting for ClinicalTrials.gov in accordance with the FDA regulations, NIH policy, and/or other ClinicalTrials.gov requirements, as applicable.
Ensures overall ClinicalTrials.gov compliance with FDAAA, NIH, and ICMJE requirements for Emory-sponsored and investigator-initiated research studies. Works collaboratively with the study team and Emory research community to track Emory-sponsored and investigator-initiated studies in ClinicalTrials.gov.
Verifies the IND status in the study protocol, eIRB, or FDA study documentation, as applicable.
Develops and facilitates training programs to accomplish goals. Thoroughly reviews complex study protocols and Informed Consent Documents (ICDs) to identify all Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might require a Prospective Reimbursement Analysis to ensure research billing compliance as internal controls for Emory University. Tracks NCT numbers for all clinical trials at Emory to ensure CMS regulations are met and the NCT is available for billing purposes for claims.
Plans and conducts independent audits and quality assurance to assess compliance with regulations, guidelines, institutional policies, and operating procedures for the purpose of preventing and detecting inaccuracies and mismanagement, while promoting accountability and efficiency within OCR teams. Prepares and distributes report of findings and metrics to the Executive Director and appropriate members of the Leadership Team, as applicable. Facilitates and tracks corrective action plans, in support of management to foster completion and achieve compliance.
Reviews Clinical Trial and Applicable Clinical Trial Determination Criteria for studies to ensure compliance with FDA, ICMJE, NIH, and Emory University policies and guidelines. Functions independently and proactively with strong critical thinking and communication skills. Manages study assignments for equitable distribution amongst team members, effectively prioritizes tasks and follows-up to ensure completion of studies in a compliant and timely manner. Effectively applies problem solving, negotiation, and continuous quality improvement methods in daily operations.
Works collaboratively and professionally with OCR staff, the Emory research community, and applicable external entities (e.g., ClinicalTrials.gov). Provides superior customer service to effectively meet the needs of internal and external customers. Provides policy and procedure interpretation to academic schools and departments/divisions related to clinical trial and research billing compliance. Actively participates in staff orientation, continuing education, and mentoring. Serves on OCR committees. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and six years of experience in research administration or a health-related field which includes direct research nurse or clinical research coordinator experience, or equivalent combination of education, training and experience. MPH or other advanced degree preferred. Thorough knowledge of clinical processes, medical terminology, and the clinical research life cycle. Proficiency with excel, access databases, and Microsoft Office.
Strong project management, leadership, analytical and organizational skills. Experience with Emory's ERMS, EPEX, and eIRB systems, as well as previous ClinicalTrials.gov experience, is highly desirable. Certification in Healthcare Research Compliance through the Health Care Compliance Association is strongly preferred within five years of hire. |
Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law. |
Human Resources