Address
Form of workCurrent 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 Hussman Institute has an exciting opportunity for a Manager, Regulatory position. The incumbent ensures that submitted research is reviewed efficiently and is consistent with regulations. The candidate ensures the accurate and timely processing, tracking, and filing of submissions to and actions by the Internal Review Board (IRB). Additionally, this employee obtains and distributes information required for Chair or IRB review, maintains files, and prepares and distributes minutes as per federal guidelines. The Manager, Regulatory documents communications with investigators, regulatory entities, and any others involved in the conduct of submitted research.
Core Job Functions
1. Develops, implements, and oversees regulatory compliance strategies.
2. Initiates development of standard operating procedures for monitoring and auditing of clinical trials.
3. Ensures trials are consistent with proposals approved by the IRB, and in compliance with applicable federal and state laws, statutes, and regulations.
4. Generates, submits, and follows up on Investigational New Drugs (IND's) submissions and Series Adverse Effects (SAE's).
5. Interfaces with and serves as liaison to regulatory agencies. Also serves as liaison to other institutional monitoring and audit groups.
6. Reviews proposed changes to submissions and advises whether the changes require regulatory approval. Responds to regulatory agencies to address questions or deficiencies in submissions.
7. Maintains regulatory agency correspondence files.
8. Trains and educates employees on regulatory requirements governing our products and operations. Identifies training and educational needs regarding clinical and manufacturing practices, and makes recommendations
9. Leads the design of monitoring programs to ensure human and animal safety.
10. Develops and monitors programs to ensure compliance with HIPAA regulations.
11. Identifies and ranks areas at risk of exposure, and recommends strategies to address such issues.
12. Develops systems and relationships to support auditing activity, and organizes panels of experts to assist in reviews and analyses.
13. Stays abreast of current regulations and trends, and ensures appropriate actions are taken to incorporate necessary revisions into workplace environment.
14. Collaborates with and provides advice to the Institutional Conflicts of Interest Committee on management plans.
15. Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
Department Specific Functions
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
#LI-GD1
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 time
Employee Type:
Staff
Pay Grade:
c106
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 Hussman Institute has an exciting opportunity for a Manager, Regulatory position. The incumbent ensures that submitted research is reviewed efficiently and is consistent with regulations. The candidate ensures the accurate and timely processing, tracking, and filing of submissions to and actions by the Internal Review Board (IRB). Additionally, this employee obtains and distributes information required for Chair or IRB review, maintains files, and prepares and distributes minutes as per federal guidelines. The Manager, Regulatory documents communications with investigators, regulatory entities, and any others involved in the conduct of submitted research.
Core Job Functions
1. Develops, implements, and oversees regulatory compliance strategies.
2. Initiates development of standard operating procedures for monitoring and auditing of clinical trials.
3. Ensures trials are consistent with proposals approved by the IRB, and in compliance with applicable federal and state laws, statutes, and regulations.
4. Generates, submits, and follows up on Investigational New Drugs (IND's) submissions and Series Adverse Effects (SAE's).
5. Interfaces with and serves as liaison to regulatory agencies. Also serves as liaison to other institutional monitoring and audit groups.
6. Reviews proposed changes to submissions and advises whether the changes require regulatory approval. Responds to regulatory agencies to address questions or deficiencies in submissions.
7. Maintains regulatory agency correspondence files.
8. Trains and educates employees on regulatory requirements governing our products and operations. Identifies training and educational needs regarding clinical and manufacturing practices, and makes recommendations
9. Leads the design of monitoring programs to ensure human and animal safety.
10. Develops and monitors programs to ensure compliance with HIPAA regulations.
11. Identifies and ranks areas at risk of exposure, and recommends strategies to address such issues.
12. Develops systems and relationships to support auditing activity, and organizes panels of experts to assist in reviews and analyses.
13. Stays abreast of current regulations and trends, and ensures appropriate actions are taken to incorporate necessary revisions into workplace environment.
14. Collaborates with and provides advice to the Institutional Conflicts of Interest Committee on management plans.
15. Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
Department Specific Functions
- A compliance specialist to be an essential part of AoURP's quality assurance program
- To cover all compliance topics across all teams (enrollment, retention, biobank, communication and data management)
- To create monthly compliance reports for the PIs on the status of compliance
- Create and maintain a master folder for all AoU compliance that includes training records, access permissions to Box/ HealthPro, SOP, etc
- To actively verify SOP document completeness and SOP adherence
- To be available for staff and PIs to explain and teach compliance processes
- To perform from time to time in-person on-site checks at sites of recruitment, retention, biobanking, communication and to observe the compliance with protocols and SOPs.
- IRB submissions: on-boarding and off-boarding staff
- To create and maintain a delegation log
- Conduct SOP and protocol refresher sessions and trainings to ensure compliance with protocol, SOPs and UHealth policies
- Keep proper training and meeting documentations
- To provide material to regulatory PI (Prof. Isasi) for the drafting/creation of regulatory documents, such as ISIA and incidence reports
- Work towards a unified compliance oversight for all SEEC partners and report quarterly on status to all organizational PIs within SEEC
- Responsible for conducting research documentation reviews of the UHealth policies, rules and regulations
- Maintain the Research Training Certification database, Investigators' Curriculum Vitae (CV) and Medical License folders and inputs/updates regulatory fields without delay
- Identify and report general compliance issues that may arise through the work process
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
- Bachelor's Degree in relevant field.
- Minimum 5 years of relevant experience.
#LI-GD1
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 time
Employee Type:
Staff
Pay Grade:
c106
