Clinical Research Manager jobs in Novi, MI

Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager 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 Research Manager 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 Research Technician / Assistant
  • University of Michigan
  • Ann Arbor, MI FULL_TIME
  • How to Apply

    A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

    Summary

    This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required for the CRC-Technician position.

    Mission Statement

    Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

    Responsibilities*

    Experience as part of a team with all 8 competency domains is expected:

    • Scientific Concepts and Research Design
    • Ethical Participant Safety Considerations
    • Investigational Products Development and Regulation
    • Clinical Study Operations (GCPs)
    • Study and Site Management
    • Data Management and Informatics
    • Leadership and Professionalism
    • Communication and Teamwork

    Assist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.

    Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).

    Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).

    Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.

    In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures.

    Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.

    Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.

    Prepare and organize space for study related materials and equipment.

    The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.

    Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.

    This person may help mentor and train other CRC staff through formal and informal presentations.

    Other administrative responsibilities as assigned.

    Supervision Received:

    This position receives direct supervision and reports directly to the unit Administrator, CRC-Lead, or CRC-Project Manager.

    Supervision Exercised:

    None.

    Required Qualifications*

    Clinical Research Technician

    • Associate's Degree or equivalent in combined education and clinical research experience
    • Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)
      or
      An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
      or
      Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.


    Clinical Research Assistant

    • High School Diploma or GED

    Desired Qualifications*

    • Bachelor's Degree in Health Science or an equivalent combination of related education and experience is desirable
    • An understanding of medical terminology preferred
    • Knowledge of Michigan Medicine policies and practice
    • Familiarity with OnCore, Epic, MiCHART, and eResearch applications
    • PEERS, CITI, or NIH Protection of Human Subjects Training Certification
    • Experience with local and central IRB application processes
    • Motivated to help others

    Work Schedule

    This position supports normal business hours, Monday ? Friday with rare occasional early mornings or late afternoon?s depending on patient schedules. This is an on-campus position with opportunity for remote work.

    Work Locations

    Ann Arbor

    Underfill Statement

    This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.

    Additional Information

    Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

    Background Screening

    Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

    Application Deadline

    Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

    U-M EEO/AA Statement

    The University of Michigan is an equal opportunity/affirmative action employer.


    Job Opening ID

    245950

    Working Title

    Clinical Research Technician / Assistant

    Job Title

    Clinical Research Technician

    Work Location

    Ann Arbor Campus

    Ann Arbor, MI

    Full/Part Time

    Full-Time

    Regular/Temporary

    Regular

    FLSA Status

    Nonexempt

    Organizational Group

    Medical School

    Department

    MM Research-Clin Trial Units

    Posting Begin/End Date

    3/04/2024 - 4/01/2024

    Career Interest

    Research

  • 21 Days Ago

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Clinical Research Coord Assoc
  • University of Michigan
  • Ann Arbor, MI FULL_TIME
  • How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the posit...
  • 3 Days Ago

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Clinical Research Nurse
  • Actalent
  • Novi, MI FULL_TIME
  • Great Opportunity to Join a Growing Team!Long-Term OpportunityCompetitive PayRequirements:Active RN License in State of Michigan in good-standing1 years of experience as a Clinical Research NurseOncol...
  • 7 Days Ago

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Senior Clinical Research Coordinator
  • Topography Health
  • Ann Arbor, MI FULL_TIME
  • Topography Health is a first-of-its-kind, physician-focused clinical trials platform. We offer a full stack of tools and services to empower doctors to gather evidence within an existing practice. Our...
  • 4 Days Ago

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Clinical Research Technician/Assistant.
  • University of Michigan
  • Ann Arbor, MI FULL_TIME
  • Responsibilities* Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs. Scientific Concepts and Research Design Ethical Participant Safety ...
  • 17 Days Ago

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Surgical Services Nurse Manager
  • Clinical Management Consultants
  • Brooklyn, MI FULL_TIME
  • An excellent opportunity for an experienced Operating Room Nurse Manager with a high-quality health system in beautiful Michigan is now available. If you are an experienced Surgical Services Nurse Man...
  • 1 Month Ago

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0 Clinical Research Manager jobs found in Novi, MI area

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Physicist II- Rad Oncology - No Experience Required
  • Henry Ford Hospital
  • Detroit, MI
  • GENERAL SUMMARY: By nature of their more extensive educational experience, medical physicists with PhD-degrees in Radiat...
  • 3/29/2024 12:00:00 AM

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Research Assistant/Associate - Office of Women's Health
  • Wayne State University
  • Detroit, MI
  • Research Assistant/Associate - Office of Women's Health Wayne State University is searching for an experienced Research ...
  • 3/29/2024 12:00:00 AM

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Research Assistant - Women's Health
  • Wayne State University
  • Detroit, MI
  • Research Assistant - Women's Health Wayne State University is searching for an experienced Research Assistant - Women's ...
  • 3/29/2024 12:00:00 AM

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Research Assistant - Biochemistry
  • Wayne State University
  • Detroit, MI
  • Research Assistant - Biochemistry Wayne State University is searching for an experienced Research Assistant - Biochemist...
  • 3/29/2024 12:00:00 AM

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Research Assistant - Dept. of Neurosurgery
  • Wayne State University
  • Detroit, MI
  • Research Assistant - Dept. of Neurosurgery Wayne State University is searching for an experienced Research Assistant - D...
  • 3/29/2024 12:00:00 AM

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Research Assistant - Dept. of Oncology
  • Wayne State University
  • Detroit, MI
  • Research Assistant - Dept. of Oncology Wayne State University is searching for an experienced Research Assistant - Dept....
  • 3/29/2024 12:00:00 AM

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Associate Director, Diagnostic Medical Science Liaison (DxMSL) Great Lakes (MI, OH, IN, IL, WI, IA, ND, SD, NE, MN)
  • Eli Lilly and Company
  • Detroit, MI
  • At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare lea...
  • 3/29/2024 12:00:00 AM

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Clinical Trial Budget Specialist
  • Revival Research Institute, LLC
  • Southfield, MI
  • Unique opportunity to make an Impact in the healthcare industry... Revival Research Institute, LLC was established in 20...
  • 3/28/2024 12:00:00 AM

Novi (/ˈnoʊvaɪ/ NOVE-eye) is a city in Oakland County in the U.S. state of Michigan. As of the 2010 census, the population was 55,224, an increase over the 2000 census count of 47,386. The city is located approximately 25 miles (40 km) northwest of the center of Detroit, and about 8 miles (13 km) west of the western border of Detroit. It is about 25 miles (40 km) northeast of the center of Ann Arbor. The city is located within the boundaries of the survey township of Novi Township. The remaining unincorporated township is only a tiny fraction surrounded by the city. According to the United St...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$101,678 to $134,717
Novi, Michigan area prices
were up 1.3% from a year ago

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