Regulatory Analyst 2

University of Miami; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

University of Miami/UHealth is hiring a Full Time Regulatory Analyst 2 for the SCCC division, based at the UHealth medical campus in Miami, FL. The role focuses on regulatory submissions from study start-up through closure and maintaining regulatory documents to ensure compliance with applicable regulations.

Key duties include coordinating IRB submissions, maintaining DOAL and regulatory binders, and supporting investigators and study staff in achieving audit readiness.

Qualifications

• Bachelor's degree in a relevant field; CCRP if applicable.
• Experience with regulatory submissions and study start-up processes.
• Strong attention to detail and written/oral communication skills.

Responsibilities

• Oversee study submissions (initial/amendments) and regulatory doc maintenance.
• Serve as point of contact for boards, committees, sponsors, and investigators.
• Coordinate and prepare regulatory documents for IRB submissions from activation to closure.

Skills

Attention to detail

Oral communication

Written communication

Education

Bachelor's degree in relevant field

CCRP certification (if applicable)

Tools

IRB submission systems

Regulatory databases

Job description

Full Time Regulatory Analyst 2 – UHealth, Miami, FL.
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 2 to work at the UHealth medical campus in Miami, FL. The Regulatory Analyst 2 – UHealth 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.

Core Responsibilities

• Oversee and provide support for study submissions (initial and amendment) and regulatory document maintenance.
• Serve as point of contact for various boards, committees, industry, academic, and cooperative sponsors.
• Submit or assist in the submission of applications for institutional clinical trials.
• Send decision correspondence to appropriate parties, requesting information.
• Assist with drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
• Maintain current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.).
• Ensure compliance of general and study-specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations.
• Adhere to University and unit-level policies and procedures and safeguard University assets.

Department Specific Functions

• Assist the senior staff of the Office of Regulatory Services (ORS) for Population Sciences and Cancer Disparity Behavioral and Community-Based Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center with day-to-day operations of the office.
• Assist with the following studies:
• Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, and sponsors.
• Complete the new protocol submission packet with information provided by PRMC as well as any additional required documentation (e.g., local protocol, HIPAA forms, etc.).
• Modify and standardize consent forms for IRB submission.
• Compile documents to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations.
• Coordinate this process from study activation through completion of the study.
• Prepare and maintain regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional SOPs, sponsor requirements (as applicable), and applicable regulatory requirements.
• Communicate with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL).
• Ensure, with the DOAL, that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• Communicate with Research Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.
• Provide updates to the study team and/or management regarding submission statutes and approvals (e.g., initial and amendments) during internal team meetings and upon request.
• Assist with various regulatory related projects under the direction of the Manager of Regulatory.

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.

Minimum Qualifications

• Bachelor's degree in relevant field (CCRP if applicable).
• Minimum 2 years of relevant experience.
• Knowledge of relevant federal, state, and local regulations.
• Knowledge of procedures associated with clinical trials.
• 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.
• Any appropriate combination of relevant education, experience and/or certifications may be considered.

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 groundbreaking 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.

Equal Opportunity

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status: Full time
Employee Type: Staff

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. 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.