University of Miami
Clinical Trial Disclosure (CTD) Associate - Hybrid
University of Miami, Coral Gables, Florida, United States
Clinical Trial Disclosure (CTD) Associate - Hybrid page is loaded## Clinical Trial Disclosure (CTD) Associate - Hybridlocations:
Coral Gables, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100090916## **Current Employees:**If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click
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 .**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 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
for additional information.**Job Status:**Full time**Employee Type:**Staff**Pay Grade:**A10The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit
to learn more about our points of pride.The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.**Transforming lives**With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service. #J-18808-Ljbffr
Coral Gables, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100090916## **Current Employees:**If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click
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 .**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 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
for additional information.**Job Status:**Full time**Employee Type:**Staff**Pay Grade:**A10The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit
to learn more about our points of pride.The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.**Transforming lives**With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service. #J-18808-Ljbffr