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Part-Time Study Coordinator

Aperia Medical
Livonia, MI

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Job Details

Part-time | Contract
$20 an hour

Benefits

Flexible schedule

Qualifications

Teamwork
Clinical research
Informed consent
Research ethical considerations
HIPAA
Attention to detail
Project management experience in healthcare
Informed consent procedures implementation
Health information regulatory compliance
Organizational skills
Managing projects
Research regulatory compliance
Good Clinical Practice (GCP)
Clinical confidentiality policies
Research and development project management
Associate's degree
Medical terminology
FDA regulations

Full Job Description

About Aperia

Aperia Medical is a health technology company developing AI-based software for breast ultrasound imaging. Our tools are designed to improve detection of breast cancer by helping radiologists find suspicious lesions earlier and characterize them more accurately. The deep learning models we develop are trained and validated on ultrasound exam images that we collect from local patient volunteers, referred to us by surrounding hospitals and partner care providers.

Overview

Aperia Medical is seeking a detail-oriented Study Coordinator to manage day-to-day project operations on a part-time basis. This role is central to our ultrasound case accrual efforts, regulatory compliance, and data quality as we expand our clinical evidence base.

We are seeking a dedicated Part-Time Study Coordinator to support subject recruitment and data collection efforts in Livonia, MI. This vital role involves managing and coordinating our IRB-approved engineering studies and supporting the overall success of our product development projects. As a Study Coordinator, you will play a key role in facilitating smooth operations of our clinical case collection initiatives within a cross-functional team of subject matter experts. This position offers an exciting opportunity for individuals passionate about clinical research and healthcare compliance to make a meaningful impact while working flexible hours.

Responsibilities

Serve as a primary point of contact and liaison with referral sites, potential participants, enrolled subjects, and project staff.
Oversee the recruitment, screening, and enrollment of study participants in accordance with protocol guidelines.
Track and report on case accrual metrics, flagging enrollment gaps or risks to study timelines.
Maintain accurate, audit-ready records of consent, eligibility, and case-level data in compliance with HIPAA and applicable regulations.
Coordinate study activities, including scheduling participant visits, collecting data, and ensuring adherence to study timelines.
Review and verify clinical documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP standards.
Monitor participant progress through data collection, medical records verification, and follow-up on clinical outcomes.
Maintain detailed records of study activities and ensure data integrity.
Ensure strict compliance with healthcare regulations such as HIPAA and healthcare ethical guidelines throughout all study processes.
Perform protocol procedures, such as automated tomographic breast ultrasound (ATBUS) image acquisition on eligible volunteers who have provided written informed consent to participate in the case collection study.

Experience

Associate's degree or equivalent experience relevant to life sciences, public health, clinical research, or related field
2+ years of experience in clinical research coordination, preferably in medical imaging, oncology, or medical device/diagnostics settings.
Working knowledge of IRB processes, informed consent procedures, and human subjects research regulations (45 CFR 46, HIPAA).
Excellent written and verbal communication skills for coordinating across clinical and technical teams
Knowledge of medical terminology, clinical laboratory procedures, and data management practices.
Familiarity with FDA regulations, ICH GCP guidelines, and HIPAA compliance standards.
Strong organizational skills with project management experience in clinical development or research settings are essential to succeed in this position.

Preferred

Bachelor's degree relevant to life sciences, public health, clinical research, or related field
Supervising experience in clinical research or healthcare settings
Proven management of clinical trials or research projects within a healthcare or laboratory environment.
Certification in ICH GCP (Good Clinical Practice) from a recognized training program
Background in nursing or experience working as a medical imaging technologist

Pay: $20.00 per hour

Benefits:

Flexible schedule

Application Question(s):

While this is a hybrid position, working mostly from home, will you be able to reliably commute to Livonia, MI 48154, as needed, for certain on-site responsibilities of this job?
Do you have the minimum skillset and experience to compliantly work in a clinical study coordinator role, undertaking the standard responsibilities, and adhering to ICH GCP and federal research regulations?
Do you understand and accept that this part-time position is paid hourly, without any additional benefits?
What aspects of this job opportunity motivated you to apply and why?

Education:

Associate (Required)

Experience:

Clinical research: 2 years (Required)

Ability to Commute:

Livonia, MI 48154 (Required)

Work Location: Hybrid remote in Livonia, MI 48154

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