University of Miami
Regulatory Analyst 1 page is loaded## Regulatory Analyst 1locations:
Miami, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100087354## **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 .The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work remotely.**CORE JOB SUMMARY**The Regulatory Analyst 1 – UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment matrix to identify possible cancers from claims data.**CORE JOB FUNCTIONS**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.***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
**Experience:**Minimum 1 year of relevant experience**Knowledge, Skills and Attitudes:*** Skill in completing assignments accurately and with attention to detail.* Ability to communicate effectively in both oral and written form.* Ability to handle difficult and stressful situations with professional composure.* Ability to maintain effective interpersonal relationships.* Ability to understand and follow instructions.**Department Specifics:**Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors. Provides regulatory support for multiple clinical trials from study start-up through study closure. Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.
Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. 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. Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.***#LI-YC1***The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.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. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.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:**H8The 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
Miami, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100087354## **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 .The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work remotely.**CORE JOB SUMMARY**The Regulatory Analyst 1 – UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment matrix to identify possible cancers from claims data.**CORE JOB FUNCTIONS**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.***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
**Experience:**Minimum 1 year of relevant experience**Knowledge, Skills and Attitudes:*** Skill in completing assignments accurately and with attention to detail.* Ability to communicate effectively in both oral and written form.* Ability to handle difficult and stressful situations with professional composure.* Ability to maintain effective interpersonal relationships.* Ability to understand and follow instructions.**Department Specifics:**Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors. Provides regulatory support for multiple clinical trials from study start-up through study closure. Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.
Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. 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. Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.***#LI-YC1***The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.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. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.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:**H8The 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