Sr. Clinical Trial Disclosure Associate
University of Miami

Job Info

---

Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Sr. Clinical Trial Disclosure (CTD) Associate to work at the University of Miami.

CORE JOB SUMMARY

The Senior Clinical Trial Disclosure (CTD) Associate within the Clinical Research Management & Support Office (CRMSO) assists with the development, oversight, and monitoring and facilitation of support systems for CTD at the University of Miami. Under the direction of the Clinical Research Management & Support Director, this position is responsible for facilitating program activities and requirements for clinical trials disclosure. The objective is to support Principal Investigators (PIs) and the university to remain in compliance with federal, state, and local regulations and requirements.

CORE JOB FUNCTIONS

• Provides clinical trial determination reviews in the capacity of CTD Ancillary Review Committee lead.
  
• 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.
  
• 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 RQA related databases and electronic filing system.
  
• Uses electronic systems (i.e., IRB10, Velos, InfoEd, RSS, clinicaltrials.gov, REDCap, ClickUp) for monthly compliance report creation and dissemination. Develop systems to prospectively identify and track studies with required results reporting.
  
• Assists investigators and research teams for protocol registration and results data entry.
  
• Develops and maintain strong internal relationships across all levels of the organization.
  
• Develops and oversee the creation 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.
  
• Maintains personal accountability for professional growth.
  

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, Health care, 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 regards 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 design and methods of data collection.
• Ability to manage multiple tasks simultaneously under minimal supervision.
• Excellent English (verbal and written) communication skills and interpersonal skills with the ability to deal professionally with all types of information, including that of a confidential nature, required.
• Strong organizational skills with strong attention to detail/accuracy and able to set priorities.
• High-level interpersonal skills are required.
• Experience with computer systems and software, including databases, spreadsheets, and word processing. Proficiency in MS Office applications.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:
Full time

Employee Type:
Staff

Pay Grade:
c107

This job has expired.