Regulatory Analyst 2 - Remote

University of Miami; Miami (FL); Remote; USD 50,000 - 90,000; Full time

Job summary

An innovative institution is seeking a Regulatory Analyst II to support regulatory submissions and ensure compliance throughout the study lifecycle. This role is crucial for maintaining regulatory documents and facilitating communication with various stakeholders, including institutional boards and research teams. The ideal candidate will possess strong organizational skills and a keen understanding of clinical trial processes. Join a vibrant team dedicated to advancing research compliance in a dynamic environment where your contributions will make a significant impact on the success of clinical studies. This is a fantastic opportunity for professionals looking to grow in the regulatory field.

Benefits

Medical Insurance

Dental Insurance

Tuition Remission

Comprehensive Benefits Package

Qualifications

• Minimum two years of experience in compliance, research, or medical/clinical fields.
• Bachelor's degree in a relevant field is required.

Responsibilities

• Oversee study submissions and regulatory document maintenance.
• Assist in submission of applications for clinical trials.
• Ensure compliance with federal and institutional regulations.

Skills

Interpersonal Relationships

Effective Communication

Problem Analysis and Decision Making

Data Organization and Analysis

Time Management

Proficiency in Microsoft Office

Knowledge of Clinical Trials

Knowledge of Regulations

Education

Bachelor's Degree in relevant field

Tools

Microsoft Office

Adobe Acrobat

Job description

Regulatory Analyst 2 - Remote

Location: Miami, FL

Time Type: Full time

Posted on: Posted 12 Days Ago

Job Requisition ID: R100072920

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:

1. 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.
2. Submits or assists in the submission of applications for institutional clinical trials.
3. Sends decision correspondence to appropriate parties, requesting information.
4. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
5. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures.
6. 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, provide solutions and make 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply.