- Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies.
- Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
- Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
- Provides support to investigators by reviewing submissions for content.
- Sends decision correspondence to appropriate parties, requesting information.
- Maintains accurate databases and generates letters.
- Develops and maintains templates, creates files, and mails notices.
- Adheres to University and unit-level policies and procedures and safeguards University assets.
- Ability to maintain effective interpersonal relationships
- Ability to communicate effectively in both oral and written form
- Skill in collecting, organizing, and analyzing data
- Proficiency in computer software (i.e., Microsoft Office)
- Oversees and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance2. Serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. 3. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. 4. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. 5. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets. 6. Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations.7. Train study teams on the policies and procedures of the Clinical Research Services.8. Maintain the regulatory and subject binders of multiple research project.
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Regulatory Analyst - Miami, United States - University of Miami
Description
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 \_eRecruiting\) .
The University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the Department of Research.
The Regulatory Analyst will be responsible for conducting the on-site audits, reviewing consolidated records (the results of the records once the new data are added), designing, reviewing and testing the revised treatment matrix which will identify possible cancers from claims data.
CORE JOB FUNCTIONS
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 relevant field
Certification and Licensing:
Not Applicable
Experience:
Minimum 1 year of relevant experience
Knowledge, Skills and Attitudes:
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine.
Patient safety is a top priority.
As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination.
Failure to meet this requirement will result in rescinding or termination of employment.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:
H7
The 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.
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.
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.
