Clinical Trial Disclosure (CTD) Associate - Hybrid

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CORE JOB SUMMARY ​                                                                   

The Clinical Trial Disclosure Associate within the Research Regulation, Integrity, Security & Evaluation Office assists with the development, oversight, monitoring and facilitation of support systems for Clinical Trial Disclosure (CTD) at the University of Miami under the direction of the Director for Human Subject Research Office and the Assoc. Vice Provost for Research Regulation, Integrity, Security & Evaluation. The CTD Associate is responsible for facilitating program activities and requirements for clinical trials disclosure. The CTD Associate reports to the Sr. Clinical Trial Disclosure Associate. The objective is to facilitate Principal Investigators (PIs) and the university to remain in compliance with federal, state, and local regulations and requirements. 

Core Job Functions                                                             

• Provides guidance and support to research community regarding ClinicalTrials.gov database.
• Reviews records to assess compliance with external and internal Clinical Trial Disclosure Requirements.
• Generates notifications to Investigators and Study teams of issues and/or errors of records as well as when results reporting are due and other notifications, as needed.
• Drafts, prepares, and presents CTD educational programs and conducts training to PIs and study teams.
• Creates and maintains ClinicalTrials.gov Protocol Registration and Result Reporting (PRS) user accounts.
• Facilitates CTD Awareness associated with federal regulations and any new requirements.
• Maintains and tracks CTD activities, reports, responses, and follow-up via CTD related databases and electronic filing system.
• Uses electronic systems (i.e. IRB 10.5, Velos, Redcap, Access) for report creation and dissemination.
• Assists with the development of systems to prospectively identify and track studies with required results reporting.
• Assists investigators and research teams for protocol registration and results data entry.
• Supports the Sr. CTD Associate in developing and maintaining strong internal relationships across all levels of the organization.
• Supports the CTD Ancillary Review Committee lead in clinical trial determination reviews.
• Collaborates on the development of resources and tools to facilitate compliance with Clinical Trial Disclosure Requirements at the University.
• Interacts with appropriate persons/agencies (e.g. Human Subjects Research Office, Billing Compliance, etc.) to resolve CTD related compliance problems.
• Participates in National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect US AMCs.
• Participates in weekly Human Subject Research Office staff meetings and educational offerings.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS                                                                                        

Education:

Bachelor’s degree in Science, Healthcare, or related field.

Certification and Licensing:

Professional certification in one of the following areas: clinical research, research compliance, GCP‐related field, etc., is highly desired but not a requirement.

Experience:

Three (3) years of work-related research experience. Any appropriate combination of relevant education, certifications and/or work experience may be considered.

Knowledge, Skills and Attitudes:

• Working knowledge of federal regulations in regard to clinical research and Good Clinical Practice (GCP) is required.
• Ability to work well with people from different disciplines (investigators and study teams).
• Familiarity with clinical research study de