Clinical Nurse Specialist jobs in Colorado

Clinical Nurse Specialist serves as a clinical expert providing teaching, mentoring, consulting, research, and systems improvement in a specific practice area or with a specific patient population. Coordinates and guides clinical activities/projects of nurses within a practice area. Being a Clinical Nurse Specialist collaborates with members of the health care team to design and implement safe, cost-effective, and evidence-based care strategies. May require a master's degree in nursing. Additionally, Clinical Nurse Specialist requires Registered Nurse (RN) License. Typically reports to a manager or head of a unit/department. The Clinical Nurse Specialist manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Nurse Specialist typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Clinical Product Regulatory Specialist
  • CPC Clinical Research
  • Aurora, CO FULL_TIME
  • We are looking for a Clinical Product Regulatory Specialist to join our team!


    The Clinical Product Regulatory Specialist is responsible for management of regulatory and investigational product (IP/IMP) activities to support CPC’s clinical trials. This includes managing and developing (where necessary) internal processes as well as managing external service providers [Contract Manufacturing Organizations (CMOs)] used for product supply, including labeling and production, and distribution and shipping of IP in compliance with applicable regulations and coordination of supporting regulatory documents.


    Regulatory Responsibilities:


    • Ensure that the organization follows the requirements outlined by the Food and Drug Administration (FDA) and other relevant regulatory agencies.
      • Maintain relationships with the regulatory agencies that oversee their industries including ex-U.S.
      • Serve as a liaison between regulatory agencies and other related organizations.
      • Ensure that all CPC’s documentation remains accurate and up-to-date.
      • Prepare regulatory document templates for distribution to clinical sites.
      • Provide regulatory support to the Operations teams, including ensuring all trials are conducted in accordance with all relevant regulations.
      • Report adverse events to regulatory authorities including ex-U.S., as needed.
      • Review and approve site-level regulatory documents.
    • Submit to and maintain public trial database postings, such as clinicaltrials.gov, EudraCT, etc.
    • Submit study-level documentation to central Institutional Review Boards (IRB) or Ethics Committees (EC).
    • Prepare and submit country-level study applications, updates, and ongoing annual reporting to the US Food & Drug Administration (FDA).
    • Lead preparation and submission of periodic reports to health authorities.

    Supply Management Responsibilities:


    • Oversee internal requirements and liaise with external parties in the coordination of IP lifecycle activities for trials including importation, depot management, labeling, distribution to sites/subjects, and certification of destruction at end of study.
    • Establish and document supply chain, supply planning/forecasting to ensure alignment with study activity and timelines.
    • Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues.
    • Manage, reconcile, maintain, and report IP inventory to assure proper distribution of IP to study sites.
    • Develop excellent working relationships with Quality Assurance (QA) for timely review and approval of batch records for packaging and labeling of IP.
    • Follow up on reported Temperature Excursions and/or Product Complaints from sites/depots.
    • Ensure expiry extensions are provided to depot/sites as needed to support continued use.
    • Manage return and destruction of IP, with proper documentation of all steps.
    • Ensure appropriate documentation of IP supply activities is filed in the Trial Master File.
    • Assist the Legal team with selection and contracting of Interactive Response Technology (IRT) and drug supply providers.
    • Facilitate the design, review, implementation of the IRT.


    Qualifications:


    • Bachelor’s degree or higher in health or life sciences, required.
    • Minimum of 5 years’ experience in the pharmaceutical/biotechnology industry performing international clinical trial regulatory management in drug development required, with at least 3 years of management experience in regulatory matters.
      • 2 years of product supply logistics/management preferred
    • Experience interpreting clinical trial protocols.
    • Experience interacting with drug depots, management or importation companies in the context of clinical trials.
    • Understanding of safety reporting regulations and guidelines.
    • Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives.
    • Experience with IRT System design, implementation, user testing and monitoring.
    • Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, etc.) and Electronic Data Capture systems.
    • Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication, including experience with conflict resolution and team alignment.
    • Great attention to detail.
    • Ability to mentor as well as work with others in a manner that promotes group effort and achievement.

    Targeted Compensation: $90,000 - $102,000 annually


    Deadline to Apply: April 1, 2024


    Note: Viable applicants will be required to pass a background and education verification check.


    About CPC:


    CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.


    CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.


    CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/


    CPC offers:


    • Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
    • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
    • 11 paid holidays
    • 15 - 25 vacation days based on years of service
    • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
    • In-suite exercise and relaxation room
    • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
    • Flexible and remote work schedules

    An Equal Opportunity Employer


    CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.


    Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.

  • 4 Days Ago

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Clinical Nurse Educator
  • Syneos Health Clinical
  • Denver, CO FULL_TIME
  • Description You’re a nurse, a patient advocate and an educator—and you excel at every one of them. In this role, the Clinical Nurse Educator (CNE) will be a key player in the education and support of ...
  • 20 Days Ago

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Clinical Trial Drug Supply Specialist
  • CPC Clinical Research
  • Aurora, CO FULL_TIME
  • We are looking for a Clinical Product Regulatory Specialist to join our team! The Clinical Product Regulatory Specialist is responsible for management of regulatory and investigational product (IP/IMP...
  • 2 Days Ago

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Medical Surgical Clinical Nurse Coordinator Night Shift
  • Clinical Management Consultants
  • Evergreen, CO FULL_TIME
  • An exceptional career opportunity for Medical Surgical Med Surg Clinical Nurse Coordinator is now available with a prestigious non profit hospital in serene and beautiful Colorado. The Medical Surgica...
  • 19 Days Ago

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Accounts Payable Specialist
  • CPC Clinical Research
  • Aurora, CO FULL_TIME
  • We are looking for an Accounts Payable Specialist to join our team! At CPC, we rely on a meticulous financial system to drive our business forward. The Finance department keeps that system running smo...
  • Just Posted

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Vaccine Sales Specialist
  • Syneos Health Clinical
  • Littleton, CO FULL_TIME
  • Description You have what it takes: a competitive drive coupled with exceptional sales ability. In this role, you will provide critical oversight on matters related to the project and responsible for ...
  • 4 Days Ago

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Clinical Nurse Specialist
  • Children's Hospital & Research Center
  • Oakland, CA
  • Position Summary: A Clinical Nurse Specialist (CNS) is a Masters prepared Advanced Practice Registered Nurse whose funct...
  • 3/28/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Bjc Healthcare
  • Saint Louis, MO
  • Job DescriptionAdditional Information About the Role Seeking a Certified Clinical Nurse Specialist with Tele Critical Ca...
  • 3/28/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Children's Hospital & Research Center Oakland
  • Oakland, CA
  • Position Summary: A Clinical Nurse Specialist (CNS) is a Masters prepared Advanced Practice Registered Nurse whose funct...
  • 3/27/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Lutheran Hospital
  • Fort Wayne, IN
  • Responsible for assessing a healthcare facility's nursing practice and its impact on patient outcomes. Provides clinical...
  • 3/27/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Clinical Management Consultants
  • Sausalito, CA
  • A great new opportunity has become available in the bay area for a Clinical Nurse Specialist within a hospital. This fac...
  • 3/24/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Clinical Management Consultants
  • San Jose, CA
  • An amazing new opportunity for a Clinical Nurse Specialist has become available at an 150+ bed acute care hospital. This...
  • 3/24/2024 12:00:00 AM

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Clinical Nurse Specialist
  • Corewell Health
  • Grand Rapids, MI
  • Corewell Health West Women’s and Infant Services includes six community hospitals as well as Butterworth Hospital, a ter...
  • 3/14/2024 12:00:00 AM

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Clinical Nurse Specialist
  • BJC HealthCare
  • Saint Louis, MO
  • Additional Information About the Role Seeking a Certified Clinical Nurse Specialist with Critical Care experience at a m...
  • 2/17/2024 12:00:00 AM

Colorado (/ˌkɒləˈrædoʊ, -ˈrɑːdoʊ/ (listen), other variants) is a state of the Western United States encompassing most of the southern Rocky Mountains as well as the northeastern portion of the Colorado Plateau and the western edge of the Great Plains. It is the 8th most extensive and 21st most populous U.S. state. The estimated population of Colorado was 5,695,564 on July 1, 2018, an increase of 13.25% since the 2010 United States Census. The state was named for the Colorado River, which early Spanish explorers named the Río Colorado for the ruddy silt the river carried from the mountains. The...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Nurse Specialist jobs
$113,269 to $138,582

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