Top Clinical Research Executive jobs in Saginaw, MI

Top Clinical Research Executive plans and directs all aspects of the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Top Clinical Research Executive ensures adherence to SOPs, Good Clinical Practice and FDA regulations. Requires an advanced degree. Additionally, Top Clinical Research Executive typically reports to top management. The Top Clinical Research Executive manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. To be a Top Clinical Research Executive typically requires 8+ years of managerial experience. Comprehensive knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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CLINICAL RESEARCH NURSE/CMED
  • Central Michigan University
  • Saginaw, MI FULL_TIME
  • This position is comprised of both clinical responsibilities and regulatory responsibilities. Clinical responsibilities may include assisting with developing and implementing the activities of a clinical research trial which consists of selection of patients, treatment procedures, drawing blood, performing EKGs, recording adverse events, withdrawals, ethical/legal practices, monitoring and audit preparation. This position may be expected to act as the primary contact with the sponsor’s study monitoring individual(s), be a resource for developing operational plans, become an expert regarding the study plan, and maintain awareness of all ongoing activities, ensuring proper handling of all paperwork. Depending upon the type and complexity of a given trial, these roles and responsibilities may be shared with or assigned to other research staff at the discretion of the Director of Clinical Research or Principal Investigator (Pl). Regulatory responsibilities include understanding of compliance with federal, state and local laws as they relate to the performance of human patient’s research, as well as preparation and maintenance of all regulatory documentation for assigned studies. This position may be responsible for presenting the study to the Institutional Review Board (IRB) and/or other departments. It is the responsibility of the position to schedule and conduct study specific training for any additional staff, within the research department as well as ancillary departments.

    Required Qualifications
    Graduation from an accredited school of nursing.
    Current registration with the State of Michigan Board of Nursing as a Registered Nurse (RN).
    Certificate of completion for CITI training or willingness to obtain certification.
    One year nursing experience related to the duties of the position.
    Strong interpersonal and communication skills required.
    Ability to analyze and interpret data and maintain confidentiality required.

    Preferred Qualifications
    Bachelor of Science in Nursing degree.
    BLS certification.
    Experience conducting single/multicenter clinical trials, human subject research or similar activities.

    Duties & Responsibilities
    Acts as a liaison between hospital physicians and principal investigator (PI). Professionally interacts with physicians, hospital committees, etc.
    Works collaboratively with investigator, sub-investigators, referring physicians, patients and their families, other clinical research coordinators, vendors, research organizations, and hospital staff.
    Continually networks at sponsored research events as a representative for CMU College of Medicine. Develops and collaborates with research sponsors for upcoming research studies.
    Acquires and maintains thorough knowledge of current research procedures, guidelines, federal regulations, and specific protocol requirements.
    Recruits consent study patients and establishes a patient/coordinator relationship. The CR-RN must be attentive to patient’s specific needs and discuss them with the Pl.
    Coordinates all aspects of research study exercises.
    Carries out assigned work as required for specific duties related to study preparation, execution, and post-study documentation.
    Performs study-specific duties, including but not limited to, completion of case report forms, coordinating/tracking patient visits, and receipts and processing of various reports generated by sponsor, site liaison for sponsor/monitors, and query resolution.
    Assesses patients for consenting into clinical trials based on inclusion/exclusion criteria. Executes and conducts study visits.
    Prepares documentation as required by the study sponsor and/or the Pl.
    Trains study patients under direction of the Pl.
    Conducts the following:
    Lab set-up and take-down for study exercises.
    Collection of capillary and venous blood samples.
    Collection, processing and shipment of any lab specimens required per protocol to include but not limited to stool, sputum samples etc.
    Plasma processing for testing and/or plasma.
    Preparation for storage/shipment of lab samples supplies and study medication.
    Data entry into spreadsheet or database.
    Develops, prepares, and presents new project proposal packets, annual reviews, and interim study documents for submission to the Institutional Review Board. This may include the following: creation of drafts for informed consent forms, abstracts, communications with sponsors and/or committees, determination of consent form changes per protocol Amendments, presents new study information to the Institutional Review Board-New study packet, revisions, Serious Adverse Events, Protocol Deviations etc.
    Provides regulatory documents to the study sponsor and maintains contact with the sponsor throughout the study regarding regulatory issues.
    Creates, updates, and maintains regulatory documents.
    Completes adverse event reporting, preparation for monitor visits, and internal/external audits, as necessary.
    Maintains supply inventory, reorders as necessary, and receives and inspects research materials.
    Performs quality control activities and initiatives.
    Researches patient bills and adjustments as needed.
    Develops monthly invoices for services provided related to research studies and research studies completed by other organizations, i.e. MCVI, Neurology, Orthopedics, Wound Care etc.
    Collaborates with Finance for the completion of all monthly reports.
    Provides training to new employees, employees in ancillary departments and volunteers.
    Participates in unit conferences and continuing education activities to meet institutional and departmental requirements.

    Supervision Exercised
    None.

    Message to Applicants
    Central Michigan University is dedicated to fostering a broadly diverse and inclusive campus that respects all social identities, experiences, and perspectives. In an effort to further this initiative, we are especially interested in candidates who will advance and promote an inclusive and supportive environment for every member of our university community.

    You must submit an on-line application in order to be considered as an applicant for this position.

    Cover letters may be addressed to the Hiring Committee.

    If there is another document you wish to include that is not required, please utilize Other Document (1).

    Position will remain open until filled. The university reserves the right to close the recruitment process once a sufficient applicant pool has been identified. For best consideration, please submit application materials before Sunday, January 28, 2024.

    Employee Group
    Professional & Administrative -Salary

    Staff Pay Level

    Pay Range
    $75,000 - $90,000

    Division
    Academic Affairs

    Department
    College of Medicine

    Position Status
    Provisional

    Position End Date
    06/30/2024

    Employment Status
    Full-Time

    FTE
    1.0

    Position Type
    12 month

    Weekly Work Schedule
    M-F 8:00 a.m. - 5:00 p.m.; evenings and weekends as required

    Location
    Saginaw, Michigan

    About the Department

    About CMU
    Central Michigan University has a more than 125-year legacy of preparing students to become leaders and changemakers in their communities and in their personal and professional lives.

    We serve nearly 15,500 students on our Mount Pleasant campus, in satellite locations around the state and throughout the country, and through flexible online programs. Many of our approximately 300 undergraduate, master’s, specialist and doctoral programs in the arts, media, business, education, human services, health professions, liberal arts, social sciences, medicine, science and engineering are nationally ranked for excellence.

    CMU leads the nation in leadership development programming through our Sarah R. Opperman Leadership Institute, and we are proud to be among only 5% of U.S. universities in the top two Carnegie research classifications. Our faculty work with graduate and undergraduate students in areas such as Great Lakes research, medical innovation, engineering technology and more.

    Central is home to 17 men’s and women’s Division 1 sports including football, basketball, gymnastics, baseball, wrestling and more. Our student-athletes achieve great success in competition and in the classroom, capturing Mid-American Conference championships and maintaining an average cumulative GPA of 3.17.

    CMU is located in Mount Pleasant, a community that blends the best of small-town living with big-city amenities. It’s part of the culturally varied and vibrant Great Lakes Bay Region that also includes Saginaw, Bay City, Midland and the state’s largest Native American community, centered on the Saginaw Chippewa Isabella Reservation in Mount Pleasant.

    Area residents enjoy the mix of outdoor activities, cultural events, shopping and dining options, and family attractions. Other major Michigan destinations and attractions — Lansing, Grand Rapids, Detroit, Traverse City, wineries, beaches, golf and ski resorts, and many more — are within easy reach of the city’s central location in Michigan’s Lower Peninsula.

    CMU employees enjoy access to a nationally recognized wellness program along with health care and benefits that exceed regional, state and national norms.

    CMU Leadership Standards
    Central Michigan University is a place where we value students and work for their success, where we act as family, and where employees are engaged, appreciated and have extraordinary opportunities to make a difference.

    We intentionally maintain and strengthen the hallmark CMU culture that sets us apart from our peers by expecting CMU leaders and employees to model the following Leadership Standards and develop them within their teams.

    Please review the Leadership Standards before applying for this position.

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Clinical Research Assistant - Part Time
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  • Bay, MI PART_TIME
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0 Top Clinical Research Executive jobs found in Saginaw, MI area

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Remote Part Time Data Entry Work From Home Computer Job
  • Expert Analytical Solutions
  • Saginaw, MI
  • Job Description Remote Part Time Data Entry Work From Home Computer Job Work from Home Online Computer Work - Administra...
  • 3/28/2024 12:00:00 AM

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Customer Experience Supervisor
  • W.W. Williams Co
  • Saginaw, MI
  • Customer Experience Supervisor in Saginaw, MI at The W.W.Williams Company **Location:** **Experience:** Not Specified **...
  • 3/28/2024 12:00:00 AM

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FT Customer Service Representative - Work From Home>
  • Dick's Sporting Goods, Inc.
  • Bay City, MI
  • [Customer Support / Remote] - Anywhere in U.S. / Up to $46.2K per year / Benefits - As a Customer Service Rep you'll: As...
  • 3/28/2024 12:00:00 AM

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Neonatologist
  • Pediatrix
  • Saginaw, MI
  • GREAT LAKES, BAY REGION Excellent opportunity for a full-time neonatologist to join a practice that emphasizes a team ap...
  • 3/27/2024 12:00:00 AM

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Entry-Level Data Entry Specialist (Remote)
  • Maxion Research
  • Saginaw, MI
  • Thank you for checking us out! Work From Home Data Entry Research Panelist Jobs - Part Time, Full Time This is a remote ...
  • 3/25/2024 12:00:00 AM

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Personal Assistant - Work From Home>
  • Duckbill
  • Bay City, MI
  • [Administrative Assistant / Remote] - Anywhere in U.S. / $20 per hour / Both PT & FT Available - As a Personal Assistant...
  • 3/25/2024 12:00:00 AM

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HVAC TB Controls Tech
  • Johnson Controls International
  • Saginaw, MI
  • What you will do Under general supervision, conducts preventive maintenance, repair, installation, and commissioning and...
  • 3/25/2024 12:00:00 AM

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Remote Data Entry Clerk
  • Maxion Research
  • Flint, MI
  • Remote Work From Home Data Entry Clerk for Entry Level Position Work at home position for job seekers from virtually any...
  • 3/24/2024 12:00:00 AM

Saginaw (/ˈsæɡɪnɔː/) is a city in the U.S. state of Michigan and the seat of Saginaw County. The city of Saginaw and Saginaw County are both located in the area known as Mid-Michigan or Central Michigan. The city of Saginaw is located adjacent to Saginaw Charter Township and is considered part of the Tri-City area, along with neighboring Bay City and Midland. The Saginaw County MSA had a population of 196,542 in 2013. The city is also the largest municipality within the Saginaw, Midland, and Bay City Metropolitan Area. The city of Saginaw was a thriving lumber town in the 19th century and an i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Clinical Research Executive jobs
$196,917 to $359,388
Saginaw, Michigan area prices
were up 1.3% from a year ago