Clinical Research Coordinator

Radiant Systems Inc; Lufkin (TX); On-site; USD 36,000 - 44,000; Full time

Job summary

Radiant Systems Inc. is seeking a Clinical Research Coordinator to support an ongoing medical device study with data entry, query resolution, and site coordination.

The ideal candidate has CRC experience, strong interpersonal and organizational skills, and the ability to work with diverse stakeholders. FDA/ICH-GCP knowledge and attention to detail are essential; role involves collaboration with a multidisciplinary team on plan execution.

Qualifications

• Bachelor's degree in a clinical, medical, or related healthcare field.
• Minimum 2 years of experience as a Clinical Research Coordinator or in a comparable clinical research role.

Responsibilities

• Conduct clinical studies in compliance with FDA, ICH-GCP, and applicable regulatory guidelines.
• Record patient information and test results accurately according to study protocols.
• Maintain investigational product (IP) accountability logs and related documentation.
• Identify and report suspected protocol or regulatory non-compliance to appropriate site personnel.
• Ensure IRB approval is obtained before study initiation and maintain ongoing IRB compliance throughout the study.
• Build positive relationships with patients to support engagement and retention.
• Attend site initiation visits and protocol training sessions.
• Schedule patients and conduct appointment confirmation and follow-up calls, as needed.
• Complete and maintain sponsor documentation in EDC, CRFs, and other clinical systems within required timelines.
• Organize and maintain source documents, patient files, and study records with accurate and up-to-date information.
• Follow established SOPs and clinical operating procedures.
• Assist in maintaining a clean, organized, and compliant clinical environment, including proper waste disposal when applicable.

Skills

GCP knowledge

SOPs

EDC systems

Clinical coordination

Regulatory compliance

IRB oversight

Data entry

Communication

Education

Bachelor's degree in clinical/medical field

Tools

EDC software

Job description

We are hiring Clinical Research Coordinator.

Client: Major Medical Device Client

Position: Clinical Research Coordinator

Duration: 5+ months on W2

Pay Rate: $26.00-$32.00/ Hr on W2

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Job Description

Position Summary

We are seeking an experienced Clinical Research Coordinator (CRC) to support an ongoing clinical study through data entry, query resolution, and a variety of site coordination activities.

The ideal candidate has prior CRC experience, a collaborative mindset, and the ability to work effectively with diverse stakeholders. Success in this role requires strong interpersonal skills, adaptability, diplomacy, and attention to detail.

• Conduct clinical studies in compliance with FDA, ICH-GCP, and applicable regulatory guidelines.
• Record patient information and test results accurately according to study protocols.
• Maintain investigational product (IP) accountability logs and related documentation, when required.
• Identify and report suspected protocol or regulatory non-compliance to appropriate site personnel.
• Ensure IRB approval is obtained before study initiation and maintain ongoing IRB compliance throughout the study.
• Build positive relationships with patients to support engagement and retention.
• Attend site initiation visits and protocol training sessions.
• Schedule patients and conduct appointment confirmation and follow-up calls, as needed.
• Complete and maintain sponsor documentation in EDC, case report forms (CRFs), and other clinical systems within required timelines.
• Organize and maintain source documents, patient files, and study records with accurate and up-to-date information.
• Follow established SOPs and clinical operating procedures.
• Assist in maintaining a clean, organized, and compliant clinical environment, including proper waste disposal when applicable.

Required Qualifications

• Bachelor's degree or an equivalent qualification in a clinical, medical, or related healthcare field.
• Minimum 2 years of experience as a Clinical Research Coordinator or in a comparable clinical research role.

Knowledge, Skills & Abilities

• Strong understanding of clinical research processes, including GCP, SOPs, informed consent, and safety monitoring.
• Ability to work independently while managing multiple priorities with strong attention to detail.
• Sound judgment and discretion when handling sensitive and complex information.
• Effective problem-solving, decision-making, negotiation, and influencing skills.
• Strong verbal and written communication skills; English proficiency is an asset.
• Excellent organizational and time management abilities.
• Proficiency with basic computer applications and electronic data capture (EDC) systems.
• Strong interpersonal skills and the ability to collaborate within a multidisciplinary team