Clinical Research Coordinator

TechMetro

Plano (TX)

Hybrid

USD 60,000 - 80,000

Full time

14 hours ago
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Job summary

TechMetro in Plano, Texas is seeking a Clinical Trial Coordinator to coordinate and manage trial activities in compliance with study protocols, GCP, and FDA/ICH regulations. This role involves collaborating with investigators, sponsors, and clinical staff to ensure smooth execution of trials.

Responsibilities include recruiting and screening participants, obtaining informed consent, maintaining accurate data in CRFs and EDC systems, and preparing study documents for IRBs and regulatory bodies.

Qualifications

  • Coordinate and manage clinical trial activities in compliance with study protocols and GCP.
  • Recruit, screen, and enroll participants; obtain informed consent; verify eligibility.
  • Collect and maintain accurate data in CRFs and EDC systems; monitor data quality and report adverse events.
  • Prepare study documentation, reports, and submissions for IRBs, sponsors, and regulatory authorities.
  • Collaborate with investigators, sponsors, and clinical staff to support study progress, site monitoring, and audits.
  • Coordinate and conduct study-related training for clinical and administrative staff, ensuring consistent protocol adherence.

Responsibilities

  • Coordinate and manage clinical trial activities in compliance with study protocols and GCP.
  • Recruit, screen, and enroll participants; obtain informed consent; verify eligibility.
  • Collect and maintain accurate data in CRFs and EDC systems; monitor data quality and report adverse events.
  • Prepare study documentation, reports, and submissions for IRBs, sponsors, and regulatory authorities.
  • Collaborate with investigators, sponsors, and clinical staff to support study progress, site monitoring, and audits.

Skills

Regulatory compliance (GCP FDA/ICH)
Informed consent process
Data collection and documentation
Study coordination

Education

Bachelor's degree in Biotechnology/Neuroscience/Life Sciences

Tools

CRFs
EDC systems

Job description

  • Coordinate and manage clinical trial activities in compliance with study protocols, Good Clinical Practice (GCP), and FDA/ICH regulations. (Multiple positions available.) Coordinate and manage clinical trial activities in compliance with study protocols, Good Clinical Practice (GCP), and FDA/ICH regulations, while adhering to all regulatory and ethical requirements. Recruit, screen, and enroll study participants; obtain informed consent; and verify subject eligibility in accordance with study protocols and institutional guidelines. Collect, document, and maintain accurate clinical research data in Case Report Forms (CRFs) and electronic data capture systems; monitor data quality and ensure timely reporting of adverse events, protocol deviations, and compliance issues. Assist in preparing study documentation, reports, and submissions for Institutional Review Boards (IRBs), sponsors, and regulatory authorities as required. Collaborate with investigators, sponsors, and clinical staff to support study progress, site monitoring, and audits. Coordinate and conduct study-related training for clinical and administrative staff, ensuring consistent protocol adherence, proper documentation practices, and smooth execution of trial activities.
Requirements
  • Bachelor's degree in Biotechnology, Neuroscience, Life Sciences, or a related field, or a foreign equivalent.
Note
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