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

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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

H9

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.

The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride.

The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.

Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.

The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.

Transforming lives

With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.