Clinical Research Coordinator at Iterative Health

New Albany, Indiana, United States

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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

Key technologies and capabilities for this role

Good Clinical PracticesGCPInformed ConsentPatient RecruitmentChart ReviewBlood DrawsSpecimen ProcessingIATA RegulationsClinical TrialsRegulatory ComplianceStudy ProtocolsPatient Interviews

Questions & Answers

Common questions about this position

Is this position remote or onsite?

The position is located onsite at GHP New Albany/Louisville.

What is the salary range for the Clinical Research Coordinator role?

This information is not specified in the job description.

What are the key skills required for this role?

Key skills include adhering to Good Clinical Practices (GCPs), performing blood draws and processing specimens per IATA regulations, conducting patient recruitment via chart reviews and interviews, and managing study protocols including informed consent and data verification.

Does this role involve any supervisory responsibilities?

No, this position has no supervisory responsibilities.

What makes a strong candidate for the Clinical Research Coordinator position?

Strong candidates will have experience in clinical trial coordination, knowledge of GCPs and regulatory standards, hands-on clinical skills like blood draws and ECGs, and the ability to manage patient recruitment and data integrity.

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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