University of Miami
Regulatory Analyst 2 page is loaded## Regulatory Analyst 2locations:
Miami, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100089402## **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 2 to work at the UHealth medical campus in Miami, FL.**CORE JOB SUMMARY**The Regulatory Analyst 2 - UHealth reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations.**CORE JOB FUNCTIONS**Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations. 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 2 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 ADDENDUM**# **Department Specific Functions**This individual will be responsible for assisting the senior staff of the Office of Regulatory Services (ORS) for Population Sciences and Cancer Disparity Behavioral and Community-Based Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center with the day-to-day operations of the office. This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials.
The Regulatory Analyst 2 must be able to assist with the following studies:**JOB FUNCTIONS:**Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, and sponsors. Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take place from study activation throughout the completion of the study. Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements. Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder. Communicate with Research Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit. Provides updates to the study team and/or management regarding submission statutes and approvals (e.g. initial and amendments) during internal team meetings and upon request. Assists with various regulatory related projects under the direction of the Manager of Regulatory**Department Specific Qualifications****Education:**Bachelor's degree in any relevant field**Certification and Licensing:**CCRP if applicable**Experience:**Minimum 2 years of relevant experience**Knowledge, Skills and Attitudes:*** Knowledge of relevant federal, state, and local regulations* Knowledge of procedures associated with clinical trials* Any appropriate combination of relevant education, experience and/or certifications may be considered.#LI-YC1The 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:**H9The 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 #J-18808-Ljbffr
Miami, FLtime type:
Full timeposted on:
Posted Todayjob requisition id:
R100089402## **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 2 to work at the UHealth medical campus in Miami, FL.**CORE JOB SUMMARY**The Regulatory Analyst 2 - UHealth reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations.**CORE JOB FUNCTIONS**Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations. 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 2 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 ADDENDUM**# **Department Specific Functions**This individual will be responsible for assisting the senior staff of the Office of Regulatory Services (ORS) for Population Sciences and Cancer Disparity Behavioral and Community-Based Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center with the day-to-day operations of the office. This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials.
The Regulatory Analyst 2 must be able to assist with the following studies:**JOB FUNCTIONS:**Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, and sponsors. Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take place from study activation throughout the completion of the study. Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements. Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder. Communicate with Research Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit. Provides updates to the study team and/or management regarding submission statutes and approvals (e.g. initial and amendments) during internal team meetings and upon request. Assists with various regulatory related projects under the direction of the Manager of Regulatory**Department Specific Qualifications****Education:**Bachelor's degree in any relevant field**Certification and Licensing:**CCRP if applicable**Experience:**Minimum 2 years of relevant experience**Knowledge, Skills and Attitudes:*** Knowledge of relevant federal, state, and local regulations* Knowledge of procedures associated with clinical trials* Any appropriate combination of relevant education, experience and/or certifications may be considered.#LI-YC1The 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:**H9The 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 #J-18808-Ljbffr