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Principal or Sr. Principal Engineer Software (DEE)
Melbourne, Florida, United States · On-site
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Senior
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Full-time
bachelor degree, postgraduate degree, professional certificate
Posted 31d ago
~40 hrs/week
Responsibilities
The auditor conducts routine and focused audits of human subject research protocols to ensure compliance with federal regulations and internal SOPs. They are responsible for preparing audit reports, assisting study teams with CAPA plans, and collaborating with internal compliance units.
Requirements
Requires a Bachelor's degree in Science or Health Care and at least one year of research compliance or auditing experience. Professional certification in clinical research or auditing is required, with specific certifications like RQAP-GCP or CCRC being desirable.
Full job description
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Research Quality Assurance (RQA) team within the Office of the Vice Provost for Research & Scholarship (OVPRS) has an exciting job opportunity for a Research Quality Assurance Auditor to work at the University of Miami.
CORE JOB SUMMARY The Research Quality Assurance Auditor conducts routine and focused audits of human subject research studies for compliance with federal and local regulations, guidelines and internal policies and procedures. The Quality Assurance Auditor reports to the Director, Research Quality Assurance.
CORE JOB FUNCTIONS
Conducts routine and focused audits of human subject research studies in compliance with Food & Drug Administration (FDA), Good Clinical Practice (GCP), and other federal regulations, International Council for Harmonisation (ICH-GCP) guidelines and internal policies and procedures.
Prepares written reports of observations.
Assists study teams in creating corrective and preventive action (CAPA) plans in response to internal audits.
Conducts CAPA implementation follow up reviews to ensure all actions have been completed.
Reports compliance deficiencies to RQA/OVPRS leadership and recommends appropriate corrective/preventive actions.
Monitors new legislation or changes in regulations that may affect the University’s compliance in conducting research, recommending changes to internal policies and procedures, as appropriate.
Collaborates with internal units (e.g., HSRO, EDR/IITS-U, Privacy Office, University Compliance, etc.) to resolve research-related compliance issues.
Assists with maintenance of QA databases, electronic audit files and metrics reporting.
Adheres to University and unit-level policies and procedures and safeguards University assets.
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.
CORE QUALIFICATIONS
Education: Bachelor’s degree in Science, Health Care, or related field is required. Master’s degree preferred.
Certification and Licensing:
Professional certification in at least one of the following areas is highly preferred: clinical research, Good Clinical Practice (GCP), research compliance, auditing.
Experience:
Minimum 1 (preferably 2 years) of research-related experience, including research compliance, study coordination, auditing, or monitoring experience. Working knowledge of federal regulations regarding clinical research and Good Clinical Practice (GCP) is required. Any appropriate combination of relevant education and/or work experience may be considered.
Knowledge, Skills and Attitudes:
Ability to communicate effectively in (English) both oral and written form.
Ability to establish and maintain effective working relationships with leadership, physicians, and coworkers.
Ability to deal professionally with all types of information including that of a confidential and sensitive nature.
Ability to recognize, analyze, and solve a variety of problems.
Ability to exercise sound judgment in making critical decisions.
Excellent organizational skills with strong attention to detail and accuracy.
Ability to manage numerous priorities effectively.
Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.
The University of Miami is recognized as one of the nation’s premier research institutions and academic health systems and is among the largest employers in South Florida.
With more than 20,000 faculty and staff, the University is committed to excellence and guided by a mission to positively impact the lives of students, patients, and communities locally and globally.
We are dedicated to fostering a culture where every individual feels valued and empowered to contribute meaningfully. United by shared values, the University community works together to build an environment defined by purpose, collaboration, and service.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Related keywords
FDAGCPICH-GCPOHRPIND/IDEHuman Subject ResearchCAPARQAP-GCPCHRCCCRCCCRPResearch Quality AssuranceCompliance AuditingSOPClinical Research
Delivering leading-edge patient care by the region’s best doctors, powered by groundbreaking research at The U.
Industry
Hospitals and Health Care
Company size
10,001+ employees
Headquarters
Miami, Florida
LinkedIn followers
39,826
UHealth – University of Miami Health System delivers leading-edge patient care by top-ranked physicians who treat some of the most complex cases. Powered by the Miller School of Medicine’s ground-breaking research and medical education, UHealth is the region’s only academic-based health care system. With a comprehensive network of nearly 40 outpatient facilities, its flagship hospital in the heart of Miami’s Health District, and more than 2,700 physicians and healthcare providers across South Florida, UHealth is a vital component of the community that is leading the next generation of health care. UHealth is home to Bascom Palmer Eye Institute, the No. 1 ranked eye hospital in the nation by U.S. News & World Report, Sylvester Comprehensive Cancer Center, the region’s only NCI-designated cancer center, and Desai Sethi Urology Institute, dedicated to urologic research and discovery, and a neurology and neurosurgery program ranked in the top 25 in the nation. These programs along with 100 other specialties make UHealth a trusted destination for compassionate, research-based care. UHealth is dedicated to continually developing an inclusive and rewarding culture for our talent - including hiring pledges with Military.com, AARP and a growing list of partners. UHealth has been honored on Becker's Healthcare 150 Top Places to Work List, emphasizing our commitment to the well-being and growth of our incredible faculty and staff. We also received the 2024 Platinum Bell Seal Certification by Mental Health America (MHA). The University of Miami was recognized by Forbes as one of the Best Employers for Women in 2023 and 2022. You can learn more about opportunities at UHealth at careers.miami.edu.
Offices: 1400 NW 12th Ave, Miami, Florida 33136, US · 5555 Ponce De Leon Boulevard, Coral Gables, FL 33146, US · 8932 SW 97th Ave, Miami, Florida 33176, US · 8100 SW 10 ST Plantation, Plantation, FL 33324, US · 1150 NW 14th St, Miami, FL 33136, US
How much do Science & Research jobs in Florida pay?
Based on 1167 listings with disclosed salaries, most science & research jobs in Florida pay between $72k–$190k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in Florida right now?
There are currently 6,191 open science & research positions in Florida listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Florida?
Companies currently hiring include University of Miami Health System-Uhealth, University of Miami Health System, UF Health, Florida Cancer Specialists & Research Institute, Northrop Grumman, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Florida?
Yes — 757 of the 6191 open science & research positions offer remote or hybrid work (299 remote, 458 hybrid).
How do I apply for Science & Research jobs in Florida?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.