Regulatory Analyst 1
7 days ago
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 SCCC department is seeking a Regulatory Analyst 1 that 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. The RA1 will facilitate 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.Primary Responsibilities:• Analyzes regulatory requirements, identifying potential conflicts, and has thorough knowledge and ability to apply federal regulations and University policies.
• Oversees accurate and timely processing, tracking and filing of submissions to and actions which includes monthly notifications on submissions for federally mandated deadlines.
• Assists with drafting, preparation, and presentation of programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance.
• Provides support to investigators by reviewing submissions for content.
• Sends decision correspondence to appropriate parties requesting information.
• Maintains accurate databases generate letters, develops and maintains templates, creates files, and mailing notices.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 fieldExperience: Minimum 1 year of relevant experienceKnowledge, 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.
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 timeEmployee Type:
StaffPay Grade:
H7-
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