On-Site Clinical Trials Coordinator - Regulatory & Study Ops

HR Anew; Dallas, Fort Worth (TX, TX); On-site; USD 45,000 - 55,000; Full time

Job summary

Prime Clinical Research is seeking an experienced Study Coordinator to support the day-to-day execution of clinical trials while also assisting with regulatory documentation and compliance activities on-site.

This role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and ensures trials are conducted in accordance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Qualifications

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

Responsibilities

• Screen potential research participants according to study eligibility criteria.
• Coordinate and schedule participant visits including screening, baseline, and follow-up visits.
• Guide participants through the informed consent process and answer study-related questions.
• Prepare charts, visit documentation, and study materials prior to participant visits.
• Coordinate day-of-visit workflow and ensure protocol procedures are completed.
• Perform or assist with specimen collection including blood draws.
• Process and document samples according to protocol requirements.
• Enter clinical study data into EDC systems.
• Maintain accurate source documentation and respond to sponsor data queries.
• Maintain Investigator Site Files (ISF) and regulatory binders.
• Support IRB submissions, amendments, and continuing reviews.
• Maintain delegation logs, training documentation, and essential study documents.
• Track regulatory document expirations and investigator documentation.
• Support monitoring visits, audits, and regulatory inspections.

Skills

ICH-GCP guidelines

EDC systems

Organizational skills

Phlebotomy

Education

Bachelor's degree in life sciences, healthcare, public health, or related field

Job description

Prime Clinical Research is seeking an experienced Study Coordinator to support the day-to-day execution of clinical trials while also assisting with regulatory documentation and compliance activities on-site.

This role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and ensures trials are conducted in accordance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.