Clinical Research Coordinator at Iterative Health

New Albany, Indiana, United States

Iterative Health Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Clinical Research, Gastroenterology, HepatologyIndustries

Requirements

  • Adherence to Research SOP’s, Good Clinical Practices (GCPs), study protocols, regulatory standards, FDA guidelines, and IATA regulations
  • Knowledge of principles of good clinical practices (GCPs) and adequate human subject protection (HSP)
  • Ability to perform clinical procedures including blood draws, phlebotomy, processing and shipping blood/urine specimens, vital signs collection, ECGs, and dispensing study medication
  • Compliance with sponsor requirements, patient safety, confidentiality, and high professional standards
  • Non-exempt FLSA status with no supervisory responsibilities

Responsibilities

  • Administratively and clinically manage industry-sponsored clinical trials
  • Assist in patient recruitment by performing detailed chart reviews and patient interviews
  • Discuss study protocols with patients and verify informed consent documentation
  • Review medical history of patients against inclusion/exclusion criteria
  • Schedule all patient research visits and procedures consistent with protocol requirements
  • Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations
  • Dispense study medication, collect vital signs, and perform ECGs
  • Assist with routine data verification, quality control, ensuring data integrity and consistency with protocol
  • Complete and maintain case report forms per FDA guidelines and review against patient’s medical record for completeness and accuracy
  • Function in a clinical role by conducting clinical research studies
  • Monitor patients and provide information to medical staff and other staff members for optimal outcomes
  • Develop written concise research study information/tools for staff education and patient recruitment
  • Maintain compliance of protocols and regulatory guidelines for studies
  • Act as a resource for other staff members regarding investigational issues or guidelines
  • Coordinate availability and distribution of medications for patients in a timely manner
  • Perform phlebotomy for lab work as required and complete necessary forms
  • Educate patients on all aspects of the disease process and/or clinical study
  • Plan and coordinate initiation of research study protocols and establishment of operating policies/procedures
  • Assist principal investigator and research manager with administrative tasks for day-to-day operations of research studies/projects
  • Plan and coordinate staffing of research studies, including recruitment and administration of research support staff
  • Plan, implement, and maintain data collection and analysis systems in support of research protocol
  • Monitor progress of research activities and develop/maintain records

Skills

Good Clinical Practices
GCP
Informed Consent
Patient Recruitment
Chart Review
Blood Draws
Specimen Processing
IATA Regulations
Clinical Trials
Regulatory Compliance
Study Protocols
Patient Interviews

Iterative Health

AI-driven solutions for gastrointestinal care

About Iterative Health

Iterative Health focuses on improving gastrointestinal (GI) care through the use of artificial intelligence (AI) and machine learning (ML). Their main product, SKOUT®, is an FDA-cleared device designed to help doctors detect adenomas, which are precursors to colorectal cancer. This device works alongside physician judgment to enhance the accuracy of diagnoses. In addition to SKOUT®, Iterative Health provides services that optimize clinical trials by using AI-enabled documentation technology, which improves patient care and ensures high-quality reporting across different healthcare institutions. This technology aims to make advanced care more accessible, especially to underserved populations. Unlike many competitors, Iterative Health combines AI technology with a strong focus on colorectal cancer prevention and clinical trial efficiency. The company's goal is to deliver top-tier GI care and improve health outcomes for patients worldwide.

Boston, MassachusettsHeadquarters
2017Year Founded
$182.1MTotal Funding
SERIES_BCompany Stage
AI & Machine Learning, HealthcareIndustries
51-200Employees

Benefits

Vision/Dental/ Medical Insurance
Life/Disability Insurance
Parental Leave
Stock Options
Flexible Work Hours
Unlimited Paid Time Off

Risks

Competition from tech giants in AI medical imaging threatens Iterative Health's market share.
Rapid expansion and partnerships may strain operational capabilities and resources.
Reliance on AI exposes Iterative Health to potential ethical and regulatory scrutiny.

Differentiation

Iterative Health uses AI to enhance GI care, focusing on colorectal cancer prevention.
Their SKOUT® device aids in adenoma detection, improving diagnostic accuracy in endoscopy.
AI-enabled documentation technology optimizes clinical trials, enhancing research quality and continuity.

Upsides

AI-driven predictive analytics in gastroenterology allow for personalized, effective patient care.
Partnerships with Gastro Health and One GI® expand clinical research capabilities in GI care.
$150M Series B funding accelerates AI innovations, transforming gastroenterology care.

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