Sr Regulatory Specialist
Sr Regulatory Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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 using the Career worklet please review this tip sheet.
The University of Miami/UHealth Department of Clinical Pharmacology has an exciting opportunity for a Full Time Sr Regulatory Specialist to work in the UHealth Campus.
Core Summary
The Sr Regulatory Specialist performs functions necessary to assure institutional compliance with all applicable regulations and standards of regulatory and accrediting agencies. The incumbent ensures that all regulatory license applications for University sites and laboratories are maintained current and submitted within the required due dates. This employee monitors the Corrective and Preventative Action Program. The Senior Regulatory Specialist supports the investigation and documentation of associated complaint deviation and nonconformance reports. Moreover an employee in this position supports all aspects of the internal and external auditing processes.
Core Responsibilities
- Maintains knowledge of appropriate regulatory statutory and accreditation requirements and current manufacturing and tissue practices.
- Assists in all aspects of the Quality Assurance Program.
- Maintains knowledge of all quality assurance procedures with a specific focus on those related to regulatory requirements licenses complaints CAPA deviations and adverse event reporting.
- Assists in the annual review of standard operating procedures and policies.
- Reviews change controls for regulatory impact including review of associated documents.
- Assists in the regulatory review of compliance programs associated with complaint handling and adverse event reporting.
- Manages metrics associated with job requirements to track and trend progress.
- Oversees regulatory compliance of internal quality assurance operations.
- Assists in review of complaints CAPA deviations and adverse event reports.
- Ensures that root cause(s) has/have been identified and that appropriate corrective and preventive actions have been taken.
- Assists in conducting internal and external audits including the review of auditassociated documentation and report preparation.
- Adheres to University and unitlevel policies and procedures and safeguards University assets.
Department Specific Functions
- Advises the study PI on protocol adherence requirements for protocol amendments FDA Code of Federal Regulations and ICHGood Clinical Practice compliance.
- Supervises Research Personnel in aspects of human subject protection to ensure that performance of study protocols adheres to ICHGCP and FDA guidelines.
- Initiates via email the process whereby all study subjects have a current signed and witnessed informed consent in their study record.
- Writes and formulates the Informed Consent and makes sure it contains standard required University of Miami language and format.
- Directly handles the preparation and submission to the IRB of:
- Research protocols
- Protocol amendments administrative and clarification letters
- Informed Consent forms (IC) such as the Main Consent Pregnancy FollowUp Consent Genetic Consent HIV Consent and Addendums
- Contracts
- HIPAA forms
- Translated documents
- Investigators brochures or package inserts
- Adverse events
- IND safety reports
- Data safety/monitoring reports or other sponsor reports
- Continuing/final reports
- Recruitment materials
- Questionnaires
- Protocol deviations
- Study specific menus
- Subject general guidelines
- Subject payment forms
- IRB and Jackson correspondence
- Regulatory and IRB affairs. Submit research protocols amendments corresponding IC and other documents as listed above to the IRB.
- Handle all IRB and regulatory correspondence.
- Communicate with Sponsors and Contract Research Organizations (CROs)
- Maintain records in regulatory binders per study up to date.
- Prepare for Sponsor Site Initiation Meetings
- Assist with FDA Sponsor and UM quality assurance audits
- Keep and maintain ongoing and future study protocols and informed consents up to date.
- Maintain all study staff training records up to date.
- Assist the director in maintaining and updating the standard operating procedures manual as required.
- Design and implement case report forms for investigatorinitiated projects.
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
Core Qualifications
Bachelors 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.
- Knowledge of business and management principles
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge 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 subspecialties 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. Were the challenge youve been looking for.
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:
H9Required Experience:
Senior IC
Employment Type
Full-Time
