Regulatory Analyst 1 - Remote at University of Miami in Miami, Florida

Posted in Other 17 days ago.





Job 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.


The Remote SCCC Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure.


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.


CORE QUALIFICATIONS
Education: Bachelor's Degree in relevant field


Experience: Minimum 1 year of relevant experience


Knowledge, Skills and Attitudes:
• 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)


#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.


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:

H8


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