Sr. Regulatory Analyst
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2020-11-18
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 LivesThe 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 senior leaders of the Regulatory Department of the Cancer Center Division of Clinical Research Services (CRS) with the day to day operations of the office. This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials. The Regulatory Analyst must be able to assist on the following studies:
Investigator Initiated Trials (IITs)
Industry Sponsored Trials
Cooperative Group Sponsored Trials
Compassionate (emergency/single patient) Trials
Coordinate the entire process of regulatory document submissions to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
Verify that implemented corrective and preventive actions are suitable and effective by conducting quality assurance (QA) & quality control (QC) checks on active clinical trials.
Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses.
Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (e.g., local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. In addition, must follow the entire initial submission process until the new study is approved.
Communication with PI and study team to organize and prepare submissions of Investigator Initiated protocols as well as expanded access/compassionate use cases to the various committees (e.g. Protocol Review and Monitoring Committee [PRMC]), for approval prior to IRB submission. Assist PI in addressing communications from PRMC pertaining to the initial protocol, amendments, or other changes in the study.
Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.
Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Communicate with Clinical 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.
Conduct regular internal QC of open and enrolling protocols and/or protocols determined to be of high risk to human subjects.
Preparation and submittal of IND and/or IDE applications and annual reports to the FDA for institutional clinical trials. 9. Act as liaison between investigators, study team and sponsor/Contract Research Organization (CRO) for the completion and submission of regulatory documents.
Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications
Bachelor's Degree in relevant field
Minimum 3 years of relevant experience
Knowledge, Skills and Attitudes:
Ability to maintain effective interpersonal relationships
Ability to communicate effectively in both oral and written form
Skill in collecting, organizing and analyzing data
Proficiency in computer software (i.e. Microsoft Office)
Ability to analyze, organize and prioritize work under pressure while meeting deadlines
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.Job Status:Full timeEmployee Type:StaffPay Grade:c105