University of Miami
Regulatory Analyst Full Time Bascom Palmer Eye Institute
University of Miami, Miami, Florida, us, 33222
Regulatory Analyst Full Time Bascom Palmer Eye Institute
The University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the Department of Research.The Regulatory Analyst will be responsible for conducting on-site audits, reviewing consolidated records, and designing, reviewing, and testing the revised treatment matrix which will identify possible cancers from claims data.CORE JOB FUNCTIONSAnalyzes 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.CORE QUALIFICATIONSEducation:
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).Department Specific FunctionsOversees 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.Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures.Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations.Train study teams on the policies and procedures of the Clinical Research Services.Maintain the regulatory and subject binders of multiple research projects.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission, and more.Patient safety is a top priority. As a result, during the Influenza season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients to have an annual influenza vaccination.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply.Job Status:
Full timeEmployee Type:
StaffPay Grade:
H7
#J-18808-Ljbffr
The University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the Department of Research.The Regulatory Analyst will be responsible for conducting on-site audits, reviewing consolidated records, and designing, reviewing, and testing the revised treatment matrix which will identify possible cancers from claims data.CORE JOB FUNCTIONSAnalyzes 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.CORE QUALIFICATIONSEducation:
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).Department Specific FunctionsOversees 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.Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures.Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations.Train study teams on the policies and procedures of the Clinical Research Services.Maintain the regulatory and subject binders of multiple research projects.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission, and more.Patient safety is a top priority. As a result, during the Influenza season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients to have an annual influenza vaccination.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply.Job Status:
Full timeEmployee Type:
StaffPay Grade:
H7
#J-18808-Ljbffr