Regulatory Specialist

Job description

Job location: Miami, FL

Employment Type: Full-time
Posted data: 2020-09-03
Req: R100041237
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 using the Career worklet, please review this tip sheet.

Transforming Lives

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 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.

The Clinical Research Services (CRS) division of the Sylvester Comprehensive Cancer Center is a centralized resource that enables cancer center clinical investigators easy access to support services to facilitate clinical trial management. These centralized services include assistance with protocol development, regulatory affairs expertise, IND submission, study budgeting, contract negotiation, coordination of research nursing, data management, and safety reporting for all types of studies, including therapeutic, non-therapeutic, prevention and screening trials. The CRS Office is responsible for providing multiple levels of support for clinical research activities throughout the Cancer Center.

This individual will be responsible for assisting the Regulatory Analyst (RA) with various aspects of regulatory submissions. This position will assist the Regulatory Analyst in preparing regulatory submissions and maintaining the regulatory files and binders (Trial Master File). This individual will supervise the collection and maintenance of credentialing information including Principal Investigator and study team training records, curriculum vitae, and research education records. The position will work closing with the Regulatory Department new study intake team and assist with opening new clinical trials in a timely manner.


  • Build and maintain a working relationship with regulatory staff.
  • Assist the Regulatory Analyst (RA) in various regulatory-related projects.
  • Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations.
  • Provide regulatory support for new and ongoing research studies. Includes but not limited to IRB filings, study file documentation creation and maintenance.
  • Attend required Regulatory Division meetings.
  • Create the Regulatory Division meeting minutes and agenda.
  • Update Trial Master File (TMF) for clinical research trials.
  • Assist in the collection and maintenance of credentialing information for study personnel. Includes collecting training records, curriculum vitae, CITI training, laboratory ranges and certifications, and medical licensures.
  • Track expirations and retrieve current documentation for medical licensures, CVs and laboratory accreditations.
  • Maintain IND safety reports and facilitate the documentation of Principal Investigator oversight.
  • Update the ICF Amendment & Re-consent Tracker to ensure study team personnel are effectively alerted to IRB approved amendments & ICF changes.
  • Maintain the regulatory department training files.
  • Assist in preparing regulatory documentation packets for new study submission.
  • Post regulatory documents including protocols, amendments, consent forms and safety reports to the CTMS system and/or appropriate drives.
  • Collect signatures from investigators and study staff participating in a clinical research trial.
  • Other duties as assigned.


Requirements include one of the following: (1). Completion of a bachelor’s degree plus a minimum of one year directly related experience in clinical research trials; or (2). Completion of a bachelor’s degree plus a minimum of two years closely related research experience; or (3). Completion of an associate’s degree plus four years’ experience in research or clerical settings to become familiar with the basic techniques and methods used to collect, compile, verify and store information.


  • Good verbal and written communication and organizational skills.
  • Ability to work well with a team of study personnel (PI, data and clinical).
  • Willingness to perform other related duties incidental to the work described herein.
  • Ability to manage multiple tasks simultaneously and independently.
  • Experience with computer systems and software, including databases, spreadsheets, and word processing. Experience with Microsoft Office software.
  • Familiarity with clinical research protocols including human subjects applications and informed consent documents.
  • Able to maintain patient confidentiality.
  • Familiarity with medical terminology.

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 for additional information.

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Full time

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Job No:
Posted: 9/9/2020
Application Due: 12/8/2020
Work Type: