Clinical Research Director jobs in Saint Paul, MN

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Clinical Research Specialist
  • Mainstay Medical
  • Brooklyn, MN FULL_TIME
  • Mainstay Medical

    Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

    The Role:

    The position is responsible for the conduct of clinical investigations including, but not limited to, ensuring the clinical investigation is conducted and monitored, and that the data are generated, documented and reported in compliance with clinical investigational plan, and applicable standards and regulatory requirements. As well as establishing and maintaining the relationship with investigators and study sites, this position works closely with the study lead, Director of Clinical Affairs, Research, Product Development, Regulatory Affairs, and Quality to ensure clinical studies are scientifically valid, meet relevant regulatory requirements and are conducted within ethical guidelines.

    Position Responsibilities:

    • Partners with study leader to development and/or review clinical project deliverables, such as protocols, CRFs, investigator brochure, informed consent, study plans, and other trial related documents
    • Manages significant portions of a clinical trial; demonstrates understanding of the study as a whole and the relation of interacting processes to create a well-run study; provide contribution to the overall flow of these processes and create an efficient structure of tools to create a well-run study
    • Interacts with clinical investigators, investigational sites, CROs and consultants
    • Provides significant contribution to the evaluation of investigators and sites; performs quaification and site activation activities and development of materials; provides training to investigators and site staff; reviews site activation documents for completeness and accuracy before site initiation
    • Assists with development of site budgets and site payments
    • Monitors clinical sites; performs source verification; assesses study/site issues and implements appropriate solutions; ensures protocol compliance at sites and prepares sites for regulatory inspections and audits; encourages study enrollment; and provides ongoing training and support
    • Ensures integrity of data through data review and works with sites to quickly and effectively resolve discrepancies
    • Assists with study registration on external sites/databases
    • Assists with development and/or review of corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits
    • Ensures the study is “audit ready” at all times
    • Ensures an adequate supply of clinical devices or study supplies; tracking inventory and collaborating with cross-functional partners
    • Serves as liaison with contract monitors or field team members as needed
    • Supports the regulatory submission process
    • Supports study closure by confirming all regulatory and safety requirements have been met and sending final study closure communications
    • Contributes to various process improvement initiatives
    • Serves as a resource for inclusion of clinical data in promotional materials for accuracy of clinical content
    • May contribute to product development and/or product continuation activities.

    Qualifications:

    • Bachelors degree and a minimum of 2 years related experience, or an advanced degree without experience, or equivalent work experience.
    • Working knowledge and track-record of executing clinical trials.
    • Understanding of ISO 14155 standard and FDA regulations for clinical trials
    • Proficient computer skills (Microsoft Office, clinical data/management systems)

    The salary range for this position is $86,000 to $96,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

    Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.

  • 22 Days Ago

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Clinical Research Nurse
  • Actalent
  • Plymouth, MN FULL_TIME
  • Description:Site feasibility and protocol review• Protocol implementation: recruitment and screening of patients, informed consent process, study procedure coordination/treatment administration, inves...
  • Just Posted

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Clinical Research Manager
  • Regions Hospital
  • Saint Paul, MN FULL_TIME
  • We have an exciting opportunity for a Clinical Research Manager to join our Critical Care Research Center. The Clinical Research Manager works with the Critical Care Research Center (CCRC) Director to...
  • 1 Day Ago

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Senior Clinical Research Associate
  • Danaher
  • Chaska, MN FULL_TIME
  • At first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, ...
  • 4 Days Ago

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Clinical Research Associate II
  • AtriCure
  • Minneapolis, MN FULL_TIME
  • AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons a...
  • 4 Days Ago

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Clinical Research Coordinator
  • Jobot
  • Mankato, MN FULL_TIME
  • Be a part of cutting edge Clinical Research with hyper-growth company!!!This Jobot Job is hosted by: Garrett MathisonAre you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us y...
  • 16 Days Ago

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0 Clinical Research Director jobs found in Saint Paul, MN area

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Adjunct Assistant Professor
  • University of Minnesota
  • Saint Paul, MN
  • 1030 jobs found. Only the first 300 jobs can be displayed. Search Results List 300 rows List View Grid View Job Title Jo...
  • 3/27/2024 12:00:00 AM

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Assistant Professor of Moving Images
  • University of Minnesota
  • Saint Paul, MN
  • 1030 jobs found. Only the first 300 jobs can be displayed. Search Results List 300 rows List View Grid View Job Title Jo...
  • 3/27/2024 12:00:00 AM

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Clinical, Tenure-Track, or Tenured Assistant/Associate/Full Professor - Division of Endodontics
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 357830 Location Twin Cities Job Family Academic Full/Part Time Full-Time Regular/Temporary Regular ...
  • 3/27/2024 12:00:00 AM

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Tenure Track Associate/Full Professor: Division Director of General Internal Medicine
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 359588 Location Twin Cities Job Family Academic Full/Part Time Full-Time Regular/Temporary Regular ...
  • 3/27/2024 12:00:00 AM

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Assistant or Associate Professor
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 358689 Location Twin Cities Job Family Academic Full/Part Time Full-Time Regular/Temporary Regular ...
  • 3/27/2024 12:00:00 AM

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Large Animal Supervisor
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 358239 Location Twin Cities Job Family Animal Health Full/Part Time Full-Time Regular/Temporary Reg...
  • 3/27/2024 12:00:00 AM

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Temporary Clinical Assistant Professor
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 359766 Location Twin Cities Job Family Academic Full/Part Time Part-Time Regular/Temporary Regular ...
  • 3/27/2024 12:00:00 AM

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ABCD Research Assistant
  • University of Minnesota
  • Saint Paul, MN
  • Apply for Job Job ID 360032 Location Twin Cities Job Family Research-Support Full/Part Time Full-Time Regular/Temporary ...
  • 3/27/2024 12:00:00 AM

Saint Paul's history and growth as a landing port are tied to water. The city's defining physical characteristic, the confluence of the Mississippi and Minnesota Rivers, was carved into the region during the last ice age, as were the steep river bluffs and dramatic palisades on which the city is built. Receding glaciers and Lake Agassiz forced torrents of water from a glacial river that undercut the river valleys. The city is situated in east-central Minnesota. The Mississippi River forms a municipal boundary on part of the city's west, southwest, and southeast sides. Minneapolis, the state's ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$151,822 to $204,957
Saint Paul, Minnesota area prices
were up 1.4% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020