Manager - Research Regulatory at NYU Langone Health in New York, NY
Position
Summary:
We have an exciting opportunity to join our team as a Manager - Research Regulatory. The Regulatory Affairs Unit facilitates the clinical trial start up process as well as all regulatory submission and maintenance functions of Perlmutter Cancer Centers Clinical Trials Office (CTO). The Manager-Research Regulatory is responsible for the timely study startup of all clinical trials, as well as working with different units, departments and ancillary services to activate studies. In addition, the manager is responsible for evaluating submission timelines and reporting on these metrics quarterly and annually, and for proposing resolutions to any bottlenecks holding up the approval process. The manager provides direct oversight of all Senior Regulatory Specialists and Program Supervisors with the Regulatory Affairs Unit. This includes hiring and training of staff. The manager should be innovative and implement new ways to improve processes. Job
Responsibilities:
1. Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. 2. Interacts on behalf of principal investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. 3. Defines study start up metrics and provides quarterly and annual reports on these metrics to be presented to Cancer Center leadership. 4. Ensures staff is in compliance with institutional SOPs, FDA regulations and Good Clinical Practice guidelines. 5. Ensures staff conducts all study activation activities in line with targeted timelines for study start up. 6. Ensure staff appropriate route feasibility, inform all stakeholders and complete all submissions appropriately. 7. Serves as a resource to all regulatory staff and streamlines processes and procedures. 8. Participates in the development of training programs specific to regulatory staff. 9. Personnel Management of all pre-activation regulatory support staff including interviewing, hiring training and professional development. 10. Liaison with Quality Assurance needed regarding IND and IDE applications to the FDA. 11. Liaison with Protocol Development and Monitoring Unit for PRMC submissions as well as Investigator Initiated Trial (IIT) development. 12. Ensure appropriate communications to Disease Management Groups regarding status of pipeline studies. 13. Ensure staff is appropriately educated on federal regulations governing human subjects research. 14. Liaison with Institutional Review Board to ensure quick turnaround of review and approval on all submissions. 15. Provide support and/or coverage to Regulatory Manager of Post-Activation as needed. 16. Provide support and/or coverage to PCC Long Island CTO as needed. 17. Work with IT and other developments on special projects to improve study submissions and oversight. 18. Work with leadership to develop SOPs to improve processes. 19. Work with leadership on strategic initiatives. 20. Performs all other duties as assigned. Minimum
Qualifications:
To qualify you must have a Bachelors Degree. Full understanding of Federal Regulations and GCP Guidelines governing the conduct of human subjects research. 5
years experience with clinical trials and regulatory affairs. Experience with local and central IRBs. Experience with FDA submissions. Preferred
Qualifications:
Masters degree, Experience managing staff and oncology clinical research experience. Qualified candidates must be able to effectively communicate with all levels of the organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
We have an exciting opportunity to join our team as a Manager - Research Regulatory. The Regulatory Affairs Unit facilitates the clinical trial start up process as well as all regulatory submission and maintenance functions of Perlmutter Cancer Centers Clinical Trials Office (CTO). The Manager-Research Regulatory is responsible for the timely study startup of all clinical trials, as well as working with different units, departments and ancillary services to activate studies. In addition, the manager is responsible for evaluating submission timelines and reporting on these metrics quarterly and annually, and for proposing resolutions to any bottlenecks holding up the approval process. The manager provides direct oversight of all Senior Regulatory Specialists and Program Supervisors with the Regulatory Affairs Unit. This includes hiring and training of staff. The manager should be innovative and implement new ways to improve processes. Job
Responsibilities:
1. Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. 2. Interacts on behalf of principal investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. 3. Defines study start up metrics and provides quarterly and annual reports on these metrics to be presented to Cancer Center leadership. 4. Ensures staff is in compliance with institutional SOPs, FDA regulations and Good Clinical Practice guidelines. 5. Ensures staff conducts all study activation activities in line with targeted timelines for study start up. 6. Ensure staff appropriate route feasibility, inform all stakeholders and complete all submissions appropriately. 7. Serves as a resource to all regulatory staff and streamlines processes and procedures. 8. Participates in the development of training programs specific to regulatory staff. 9. Personnel Management of all pre-activation regulatory support staff including interviewing, hiring training and professional development. 10. Liaison with Quality Assurance needed regarding IND and IDE applications to the FDA. 11. Liaison with Protocol Development and Monitoring Unit for PRMC submissions as well as Investigator Initiated Trial (IIT) development. 12. Ensure appropriate communications to Disease Management Groups regarding status of pipeline studies. 13. Ensure staff is appropriately educated on federal regulations governing human subjects research. 14. Liaison with Institutional Review Board to ensure quick turnaround of review and approval on all submissions. 15. Provide support and/or coverage to Regulatory Manager of Post-Activation as needed. 16. Provide support and/or coverage to PCC Long Island CTO as needed. 17. Work with IT and other developments on special projects to improve study submissions and oversight. 18. Work with leadership to develop SOPs to improve processes. 19. Work with leadership on strategic initiatives. 20. Performs all other duties as assigned. Minimum
Qualifications:
To qualify you must have a Bachelors Degree. Full understanding of Federal Regulations and GCP Guidelines governing the conduct of human subjects research. 5
years experience with clinical trials and regulatory affairs. Experience with local and central IRBs. Experience with FDA submissions. Preferred
Qualifications:
Masters degree, Experience managing staff and oncology clinical research experience. Qualified candidates must be able to effectively communicate with all levels of the organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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