Clinical Research Associate III

Sunrise Systems

Behavioral Health Market Context

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Job Description

 this a temp to perm position Contract only

Posted Position Title

Clinical Research Coordinator

Role Summary/Purpose

The Clinical Research Coordinator is responsible for managing in-house clinical research for the Client Ultrasound Businesses

Essential Responsibilities

Duties include (but are not limited to):

Recruit, screen, enroll, and obtain informed consent from study participants

Coordinate and oversee research sessions, including scheduling participants, reserving space, ensuring staff training, and managing documentation

Ensure compliance with the study protocol, external standards (regulations, GCP, IRB requirements), and internal Client processes

Maintain all study documentation, including regulatory binders, source documentation, trackers, and other materials

Complete IRB submissions such as new study submissions, Continuing Review, Amendments, Deviation reports, and Adverse Event reports

Conduct training and provide guidance to a large study staff

Facilitate regular monitoring visits; prepare for audits as needed

Serve as main point of contact for research volunteers and study staff

Maintain facilities (consent area, scan bays), order supplies and track spend

Implement process improvement activities as needed

Implement electronic processes to facilitate compliance and efficiency

Provide support to Research Program Integrators as needed

Serve as a Subject Matter Expert (SME) for coordinators at global sites executing similar protocols

This role requires physical presence in the Client Research Park facility in Wauwatosa, WI during ultrasound scanning sessions.

Qualifications/Requirements

1. Bachelor's degree in science or research-related field

2. Previous experience with a minimum of 2 years in clinical research

3. Outstanding organizational skills

4. Proficient at Microsoft Office (Excel, Outlook, Word)

5. Meticulous attention to detail

6. Exceptionally well-organized

7. Excellent communication skills (written and verbal)

8. Must be willing to work in our Wauwatosa, WI facility

Desired Characteristics

1. CCRC or CCRP certified preferred

2. Previous experience as a Clinical Research Coordinator

Qualifications

  • Bachelor's degree in science or research-related field
  • Previous experience with a minimum of 2 years in clinical research
  • Outstanding organizational skills
  • Proficient at Microsoft Office (Excel, Outlook, Word)
  • Meticulous attention to detail
  • Exceptionally well-organized
  • Excellent communication skills (written and verbal)
  • Must be willing to work in our Wauwatosa, WI facility

Benefits

    Responsibilities

    • Work shift (days/times) 1st Shift
    • Travel Required (% of travel) No, just to office each day
    • The Clinical Research Coordinator is responsible for managing in-house clinical research for the Client Ultrasound Businesses
    • Recruit, screen, enroll, and obtain informed consent from study participants
    • Coordinate and oversee research sessions, including scheduling participants, reserving space, ensuring staff training, and managing documentation
    • Ensure compliance with the study protocol, external standards (regulations, GCP, IRB requirements), and internal Client processes
    • Maintain all study documentation, including regulatory binders, source documentation, trackers, and other materials
    • Complete IRB submissions such as new study submissions, Continuing Review, Amendments, Deviation reports, and Adverse Event reports
    • Conduct training and provide guidance to a large study staff
    • Facilitate regular monitoring visits; prepare for audits as needed
    • Serve as main point of contact for research volunteers and study staff
    • Maintain facilities (consent area, scan bays), order supplies and track spend
    • Implement process improvement activities as needed
    • Implement electronic processes to facilitate compliance and efficiency
    • Provide support to Research Program Integrators as needed
    • Serve as a Subject Matter Expert (SME) for coordinators at global sites executing similar protocols
    • This role requires physical presence in the Client Research Park facility in Wauwatosa, WI during ultrasound scanning sessions


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