What are the responsibilities and job description for the Regulatory Analyst 2 - Remote position at Lensa?
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Current Employees
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) 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 (https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf) .
The Remote SCCC Regulatory Analyst II 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.
Primary Responsibilities
Oversees 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.) 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 institutional SOPs, FDA, NIH, and other applicable regulations.
Requirements
Education: Bachelor's Degree in relevant field
Certification and Licensing: Not required, but recommended (e.g., SOCRA - CCRP)
Experience: Minimum two (2) years of relevant experience in fields such as compliance, research, and/or medical/clinical. IND/IDE/FDA experience preferred.
Knowledge, Skills, And Attitudes
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 here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status
Full time
Employee Type
Staff
Pay Grade
H9
Current Employees
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) 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 (https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf) .
The Remote SCCC Regulatory Analyst II 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.
Primary Responsibilities
Oversees 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.) 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 institutional SOPs, FDA, NIH, and other applicable regulations.
Requirements
Education: Bachelor's Degree in relevant field
Certification and Licensing: Not required, but recommended (e.g., SOCRA - CCRP)
Experience: Minimum two (2) years of relevant experience in fields such as compliance, research, and/or medical/clinical. IND/IDE/FDA experience preferred.
Knowledge, Skills, And Attitudes
- Ability to maintain effective interpersonal relationships
- Ability to communicate effectively in both oral and written form
- Ability to utilize sound judgment, analyze problems, provides solutions and makes decisions.
- Skill in collecting, organizing and analyzing data.
- Highly organized, proactive, and detail oriented
- Excellent skills in time-management, prioritization, and multi-tasking
- Proficiency in computer software (i.e., Microsoft Office, Adobe Acrobat)
- Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers and clients.
- Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
- Knowledge of processes associated with clinical trials
- Knowledge of applicable federal, state, and local rules and regulations
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 here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status
Full time
Employee Type
Staff
Pay Grade
H9
