Jobs
>
Pittsburgh

    Regulatory Specialist - Pittsburgh, United States - UPMC

    UPMC
    UPMC Pittsburgh, United States

    3 weeks ago

    Default job background
    Description

    Purpose:


    UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute.


    As the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well-positioned to contribute to the global effort to reduce the burden of cancer.


    UPMC Hillman Cancer Center is currently hiring a regular full-time
    Regulatory Specialist to help support the Oncology Clinical Research Services team located at the Hillman Cancer Center in Shadyside/Pittsburgh, PA.

    This role will support multiple Oncology Disease Center program(s) studies working Monday through Friday daylight hours.


    The Regulatory Specialist's purpose is to develop regulatory forms/documents using assigned clinical study materials, to usher clinical studies through the regulatory portion of the trial submission process, and to maintain the regulatory integrity of assigned clinical trials from approval to closure under the direction of the Regulatory Specialist Supervisor.

    Maintenance of the CTMS database is a crucial function of the position.


    The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman.

    These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials.

    Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.


    Responsibilities:

    • Uses a variety of resources and strategies to manage protocols and to ensure compliance with protocol procedures and all reporting requirements as well as adherence to all CRS SOPs.
    • Develops and maintains productive working relationships internally and externally by demonstrating accountability for actions, enthusiasm, motivation, and commitment to patients and colleagues.
    • Performs any other tasks that are assigned by CRS management to help the organization meet its mission.
    • Understands the ancillary UPMC committees, various regulatory agencies and sponsor submissions as per their guidelines.

    This includes an understanding of:

    preparing, submitting and tracking protocol requirements through the initial approval process, preparing and submitting modifications, annual renewals, annual reports, and fiscal forms, as well as preparing and reporting all safety and compliance events.


    • Maintains an organized and accessible regulatory file for site audit/monitoring visits, as per UPCI SOP.
    • Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral, and meeting format, while adhering to appropriate timelines.
    • Supports the development of new staff and colleagues, may also serve as a preceptor.
    • Understands the process for compiling disease center Data Safety & Monitoring Board (DSMB) meeting agendas and recording, disseminating, and submitting the minutes from the meeting to the appropriate regulatory bodies.
    • Not only identifies opportunities for quality improvement, but also actively participates in quality improvement efforts both at the departmental and organizational levels.
    • Acts as a resource concerning regulatory information for all internal and external customers.
    • Bachelor's degree in a health, law, public health, business, science or related field
      OR equivalent combination of education and/or related experience required.
    • Knowledge of clinical research trial regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential.
      OR 1 years' experience in drug development, regulatory or clinical operations functions is preferred, Exceptional writing, planning, and organizational skills are required to prepare clinical study protocols, regulatory submissions, and various scientific and medical-related reports to contribute to the overall Clinical and Regulatory effort for oncology trials.
    • Preparation and maintenance of FDA submissions and the ability to appropriately summarize data for inclusion in requisite reports is necessary.
    • Previous work or strong knowledge of oncology is preferred.
    • Strong communication, presentation and computer, and database knowledge skills are required.
    • Must be capable of functioning independently with minimal supervision as well as perform and follow up with multiple projects.

    Licensure, Certifications, and Clearances:

    • Act 34

    UPMC is an Equal Opportunity Employer/Disability/Veteran
  • University of Pittsburgh Medical Center

    Regulatory Specialist

    3 weeks ago

    University of Pittsburgh Medical Center Pittsburgh, United States

    Purpose: · UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute. · As the preeminent institutio ...

  • University of Pittsburgh

    Regulatory Specialist

    3 weeks ago

    University of Pittsburgh Pittsburgh, United States

    · Regulatory Specialist · Experience conducting regulatory activities for Coordinating Center trials preferred. · Job Summary · Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Pr ...

  • University of Pittsburgh Medical Center

    Regulatory Specialist

    3 weeks ago

    University of Pittsburgh Medical Center Pittsburgh, United States

    UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute. As the pree Regulatory, Oncology, Clinica ...

  • Advance Sourcing Concepts, LLC

    Regulatory Specialist

    3 weeks ago

    Advance Sourcing Concepts, LLC Pittsburgh, United States

    Advance Sourcing Concepts is looking for a Regulatory Specialist for a position in Pittsburgh PA. · In this position, you will have the opportunity to prepare and coordinate protocol-related documents for clinical trials. You will also serve as a resource to staff and member ins ...

  • Cook

    Regulatory Publishing Specialist

    2 weeks ago

    Cook Pittsburgh, United States

    Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of Publishing, Regulatory, Specia ...

  • Underwriters Laboratories

    Regulatory Specialist Intern

    3 weeks ago

    Underwriters Laboratories Pittsburgh, United States

    Remaining current on the status of regulations pertaining to Environmental, Safety and Health (EHS) impacting chemicals for assigned areas of responsibility. Develop procedures for routine review of the regulatory information to keep information in t Regulatory, Specialist, Inter ...

  • Cook Group

    Regulatory Publishing Specialist

    2 weeks ago

    Cook Group Pittsburgh, United States

    Overview: · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rel ...

  • Cook Medical

    Regulatory Publishing Specialist

    2 weeks ago

    Cook Medical Pittsburgh, United States

    Overview · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rela ...

  • Cook Medical

    Regulatory Publishing Specialist

    1 week ago

    Cook Medical Pittsburgh, United States

    Overview · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rela ...

  • Cook Medical

    Regulatory Publishing Specialist

    6 days ago

    Cook Medical Pittsburgh, United States

    Overview · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rela ...

  • Cook Medical

    Regulatory Publishing Specialist

    1 day ago

    Cook Medical Pittsburgh, United States

    Overview · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rela ...

  • Cook Medical

    Regulatory Publishing Specialist

    1 week ago

    Cook Medical Pittsburgh, United States

    Overview · Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. Were investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-rela ...

  • The Sherwin-Williams Company

    Regulatory Affairs Specialist

    3 weeks ago

    The Sherwin-Williams Company Sewickley, United States

    RESPONSIBILITIES: · Provide customer requested information regarding Packaging products; including declarations of compliance and maintenance of customer product regulatory spreadsheets. · Coordinate regulatory affairs matters with other departments, locations and divisions. Req ...

  • Sherwin-Williams

    Regulatory Affairs Specialist

    2 days ago

    Sherwin-Williams Sewickley, United States

    Responsibilities · RESPONSIBILITIES: Provide customer requested information regarding Packaging products; including declarations of compliance and maintenance of customer product regulatory spreadsheets. · Coordinate regulatory affairs matters with other departments, locations a ...

  • Sherwin-Williams

    Regulatory Affairs Specialist

    3 weeks ago

    Sherwin-Williams Sewickley, United States

    Responsibilities · RESPONSIBILITIES: Provide customer requested information regarding Packaging products; including declarations of compliance and maintenance of customer product regulatory spreadsheets. · Coordinate regulatory affairs matters with other departments, locations a ...

  • Sapphire Technologies

    Reference (M/F/D) Banking Supervision Law

    2 days ago

    Sapphire Technologies Millvale, PA, United States Freelance

    We are a manufacturing company specializing in solutions for the credit industry. Our team of approximately 100 employees are experts in various fields and work closely with our clients and partner companies to develop products and services. Our daily work plays a crucial role in ...

  • FusionWorks

    IT Security Officer

    1 day ago

    FusionWorks Coraopolis, United States

    As a modern and forward-thinking company, we are an important driving force for the regional economy. This is made possible by our approximately 1,700 employees who are dedicated to serving our region with energy and commitment. Our desire for continuous development motivates us ...

  • PNC Bank

    Associate Equipment Finance Specialist

    1 week ago

    PNC Bank Pittsburgh, United States

    Performs or assists in equipment finance activities. Works under supervision and may have limited approval and/or exception authority. Identifies and appropriately mitigates different types of risk, such as regulatory, reputational, operational and c Equipment, Finance, Associate ...

  • BNY Mellon

    External Reporting Specialist

    2 weeks ago

    BNY Mellon Pittsburgh, United States

    External Reporting Specialist · Bring your ideas. Make history. · BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of ...

  • Housing Opportunities Commission of Montgomery County

    Program Specialist Ii

    2 weeks ago

    Housing Opportunities Commission of Montgomery County Kensington, United States

    The Program Specialist II is responsible for coordinating social services programs for residents in various housing programs and the administration of the HUD McKinney Supportive Housing grant programs. · Work requires considerable knowledge in the principals and practices of soc ...