Clinical Research Coordinator — Study Operations & Compliance

HR Anew Inc.

Austin (TX)

On-site

USD 33,000 - 36,000

Full time

8 days ago

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Job summary

Prime Clinical Research seeks an experienced Clinical Research Coordinator to support the day-to-day execution of clinical trials and assist with regulatory documentation and compliance activities. This role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and ensures trials follow study protocols and GCP guidelines.

Candidates with CRC or Clinical Trials Coordinator experience are strongly encouraged to apply.

Qualifications

  • Bachelor's degree in life sciences, healthcare, public health, or related field.
  • Minimum 2 years of clinical research experience as a Study Coordinator or CRC.
  • Knowledge of ICH-GCP guidelines.
  • Experience using Electronic Data Capture (EDC) systems.
  • Strong organizational and documentation skills.
  • Phlebotomy or specimen collection experience.

Responsibilities

  • Coordinate and perform clinical trial activities in line with study protocol.
  • Screen and schedule participant visits, including baseline and follow-up.
  • Guide participants through consent and answer study questions.
  • Prepare charts, visit materials, and study documents for visits.
  • Enter data into EDC systems and maintain source documentation.
  • Maintain ISF and regulatory binders; support IRB submissions and regulatory inspections.

Skills

Study coordination
EDC systems
ICH-GCP
Phlebotomy
Documentation
Regulatory knowledge

Education

Bachelor's degree in life sciences, healthcare, public health, or related field
Clinical research certification (CCRC or CCRP)

Job description

Prime Clinical Research seeks an experienced Clinical Research Coordinator to support the day-to-day execution of clinical trials and assist with regulatory documentation and compliance activities. This role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and ensures trials follow study protocols and GCP guidelines.

Candidates with CRC or Clinical Trials Coordinator experience are strongly encouraged to apply.

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