Regulatory Analyst 1

UM Corp; Miami (FL); Remote; USD 55,000 - 75,000; Full time

Job summary

The University of Miami is seeking a Full-Time Regulatory Analyst 1 to join the UHealth Department. This role involves conducting audits, ensuring regulatory compliance, and providing regulatory support for clinical trials. Candidates should have a Bachelor's degree and at least one year of relevant experience. The position offers a competitive salary and benefits package.

Benefits

Comprehensive benefits package

Tuition remission

Qualifications

• Minimum 1 year of relevant experience.
• Ability to handle stressful situations professionally.
• Knowledge of federal regulations and institutional policies.

Responsibilities

• Conducts on-site audits and reviews consolidated records.
• Ensures compliance with federal regulations and university policies.
• Generates and maintains essential regulatory documents.

Skills

Attention to detail

Effective communication

Interpersonal relationships

Analytical skills

Education

Bachelor's degree in relevant field

Job description

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 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 :

Bachelors 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 Floridas 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. Were the challenge youve 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 here for additional information.

Job Status : Full time

Employee Type : Staff

Pay Grade :

Required Experience :

Key Skills

Hair And Beauty,Facilities,IT Support,Bank,Asp.Net MVC

Employment Type : Full-Time

Experience : years

Vacancy : 1

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