NYU Winthrop is a 591-bed university-affiliated medical center, which offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. We are a major regional healthcare resource with a deep commitment to medical education and research, offering a full complement of inpatient and outpatient services.
Position Summary:
We have an exciting opportunity to join our team as a Assistant Director, Clinical Trials Operations â Perlmutter Cancer Centers Clinical Trials Office (CTO) at NYU Winthrop.
In this role, the successful candidate is responsible for the day-to-day administrative operations of the Perlmutter Cancer Centers Clinical Trials Office (CTO) at NYU Winthrop. Serves as a liaison to the Perlmutter Cancer Centers central CTO, working closely with the Administrative and Clinical management for CTO Regulatory Affairs, Data Coordination, Quality Assurance, Business Operations, Biofluid Support, and Protocol Development Units. Works closely with the Research Nurse Manager at NYU Winthrop as well as the Administrative and Clinical management at Perlmutter Cancer Centers CTO at NYU Winthrop to maintain compliant and efficient clinical trials operations. Responsible for onboarding, training, mentoring and supervising Regulatory Specialists and Data Associates stationed at the NYU Winthrop location. May travel to Manhattan location as needed.
Job Responsibilities:
- Manages the day to day administrative operations of the NYU Winthrop Cancer CTO inclusive of regulatory and study start up and data management functions of the clinical trials office.
- Provides administrative support to the Research Nurse Manager and Administrative and Clinical management at Perlmutter Cancer Centers Cancer CTO as well as to the clinical team as needed.
- Provides ongoing support to Principal Investigators (PI) conducting clinical trials at the NYU Winthrop location. Ensure PIs receive efficient and continuous regulatory and data management support for cancer clinical trials conducted at the Perlmutter Cancer Centers CTO at NYU Winthrop.
- On-boards, trains, mentors and provides ongoing supervision to regulatory and data management staff.
- Develops and oversees standard orientation programs for all incoming regulatory and data management staff leveraging the central offices orientation programs, and standard operating procedures.
- Works closely with the leadership of Regulatory Affairs and Study Start Up at the Perlmutter Cancer Centers central CTO to ensure study activation timelines at NYU Winthrop are in line with the Perlmutter Cancer Centers expected activation timelines. Provides metrics on local study activation timelines, and participates in regular study activation meetings and addresses bottlenecks in the process on an ongoing basis. Ensures regulatory staff are trained consistent with central practices, and following central standard operating procedures. Serves as a liaison to central financial coordinators as issues related to billing plans, and study budgets arise. Ensures regulatory staff attend central Regulatory Affairs Unit meetings in order to remain up to date on process changes and standard practices.
- Works closely with the leadership of Data Management and Reporting at the Perlmutter Cancer Centers Central CTO to ensure data entry timelines and practices at NYU Winthrop are in line with Perlmutter Cancer Center policies and procedures. This includes the need for rapid data entry and query resolution as well as adherence to subject registration and visit tracking procedures within the institutions Clinical Research Management System. Ensures data management staff are trained consistent with central practices and following central standard operating procedures. Serves as a liaison to financial coordinators as issues related to visit completion for invoicing and sponsor billing purposes arise. Ensures data management staff attend central Data Coordination Unit meetings in order to remain up to date on process changes and standard practices.
- Provides ongoing recommendations on staffing needs for the Perlmutter Cancer Centers CTO at NYU Winthrop to the Administrative and Clinical Directors of the local and central offices on an ongoing basis using feedback from the local PIs and based on standard and defined activity metrics.
- Ensures all clinical trials available at the NYU Winthrop location are appropriately posted on the public facing clinical trials website. Develops and issues monthly All Available Trial and Accrual Activity reports to all staff and faculty.
- Ensures staff attend and participate in Disease Management Group, Protocol Review and Monitoring Committee (PRMC), Internal Audit Committee, Data and Safety Monitoring Committee, Internal Audit Committee meetings, and all other central office and local meetings as required.
- Ensures staff and PIs are adherent to the Perlmutter Cancer Centers Clinical Trials Site Management Plan and NYU Institutional Review Board (IRB) location management plans when the NYU Winthrop location serves as a satellite site, or a lead site on cancer clinical trials activating across multiple Perlmutter Cancer Center locations.
- Participates in internal audits and the development of Corrective and Preventative Action (CAPA) plans as necessary.
- Participates in the development and revision of Standard Operating Procedures.
- All other duties as assigned.
Minimum Qualifications:
To qualify you must have a Bachelors Degree.
10 years of experience in clinical trials operations including data management and regulatory affairs.
Experience with clinical trial medicare coverage analysis, billing and budget practices.
Experience working within a Clinical Trials Management System.
Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power point and Outlook.
Effective oral and written communication skills, interpersonal skills, and organizational skills.
Ability to interface effectively with all levels of management and faculty and must work and communicate effectively with both internal and external customers.
Ability to work within a team environment as well as independently.
Time management skills and ability to work well under pressure.
Ability to multi task and manage multiple projects with deadlines.
Advanced understanding of Good Clinical Practice Guidelines (GCP) and Federal Regulation governing the conduct of human subject research.
Preferred Qualifications:
Masters degree in business management or life sciences. Professional certification (CCRP from SOCRA or CCRC from ACRP)
3 years of experience managing people.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Winthrop provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where youâll feel good about devoting your time and your talents.
NYU Winthrop is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
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