Clinical Research Coordinator II at Iterative Health

Dayton, Ohio, United States

Iterative Health Logo
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Clinical Research, Gastroenterology, HepatologyIndustries

Requirements

  • Adherence to Research SOP’s, Good Clinical Practices (GCPs), study protocols, FDA guidelines, and regulatory standards
  • Knowledge of regulatory requirements, including human subject protection (HSP), IATA regulations for shipping specimens
  • Ability to perform clinical procedures: blood draws, phlebotomy, processing/shipping blood/urine specimens, vital signs collection, ECGs, dispensing study medication
  • Skills in patient recruitment: detailed chart reviews, patient interviews, verifying informed consent, reviewing medical history against inclusion/exclusion criteria
  • Proficiency in data management: routine data verification, quality control, completing/maintaining case report forms, ensuring data integrity and consistency
  • Capability to function in a clinical role, monitoring patients, and providing information to medical staff
  • Non-supervisory role (no supervisory responsibilities)
  • FLSA: Non-Exempt

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
  • Perform blood draws, process and ship blood/urine specimens per protocol and IATA regulations
  • Schedule all patient research visits and procedures consistent with protocol requirements
  • Dispense study medication, collect vital signs, and perform ECGs
  • Assist with routine data verification and quality control, ensuring data integrity
  • Complete and maintain case report forms per FDA guidelines and review against patient’s medical record
  • Monitor patients and provide information to medical staff for optimal outcomes
  • Develop written research study information/tools for staff education and patient recruitment
  • Maintain compliance with protocols and regulatory guidelines
  • Act as a resource for staff on investigational issues or guidelines
  • Coordinate availability and distribution of medications for patients
  • Perform phlebotomy for lab work and complete necessary forms
  • Educate patients on disease process and clinical study aspects
  • Plan and coordinate initiation of research study protocols, operating policies, and procedures
  • Assist principal investigator, research team, and Regional Director with administrative tasks for day-to-day operations
  • Plan and coordinate staffing of research studies, including recruitment and administration of support staff
  • Plan, implement, and maintain data collection and analysis systems in support of research protocol
  • Monitor studies (incomplete in description)

Skills

Key technologies and capabilities for this role

Good Clinical PracticesGCPInformed ConsentPatient RecruitmentChart ReviewBlood DrawsSpecimen ProcessingIATA RegulationsRegulatory ComplianceClinical TrialsStudy ProtocolsPatient Safety

Questions & Answers

Common questions about this position

What is the location for this Clinical Research Coordinator II position?

The position is located at One GI-Dayton.

Is this a remote role or does it require on-site work?

This information is not specified in the job description beyond the listed location at One GI-Dayton.

What are the key responsibilities of the Clinical Research Coordinator II?

Key responsibilities include administratively and clinically managing industry-sponsored clinical trials, adhering to SOPs, GCPs, and protocols, assisting in patient recruitment, performing blood draws, scheduling visits, dispensing medication, and maintaining data integrity.

What salary or compensation is offered for this role?

This information is not specified in the job description.

Does this position involve any supervisory duties?

No, this position has no supervisory responsibilities.

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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