Clinical Research Coordinator: Drive Trials & Participant Care

Winaxis LLC; Dallas (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Winaxis LLC is seeking a Clinical Research Coordinator (CRC) to oversee clinical trials per study protocols, GCP guidelines, and regulatory requirements. You will recruit participants, document data, and safeguard safety and data integrity.

You will coordinate day-to-day study activities, ensure protocol compliance, obtain informed consent, schedule visits, maintain regulatory files, and support sponsor visits and inspections in hospital and research settings.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Prior clinical research or trial coordination experience preferred.
• GCP certification an advantage.

Responsibilities

• Coordinate and oversee day-to-day activities related to assigned clinical studies.
• Review study protocols and ensure activities comply with protocol requirements.
• Recruit, screen, and enroll eligible study participants.
• Obtain and document informed consent from participants.
• Schedule participant visits and coordinate assessments and follow-ups.
• Collect, document, and maintain study data in CRFs and EDC systems.
• Maintain essential regulatory documents and study records.
• Monitor participant safety and report adverse events per timelines.
• Coordinate with investigators, sponsors, CROs, labs, and stakeholders.
• Prepare for sponsor monitoring visits, audits, and regulatory inspections.
• Adhere to GCP, policies, and local and international regulations.
• Track study timelines, recruitment targets, and milestones.
• Assist with initiation, amendments, close-out, and archiving of documents.
• Maintain confidentiality of participant information.

Skills

Clinical trials

ICH-GCP

Organizational skills

Communication

Attention to detail

MS Office

EDC systems

Independent worker

Team collaboration

Problem solving

Education

Bachelor's degree in Life Sciences

Tools

EDC software

Study management software

Job description

Winaxis LLC is seeking a Clinical Research Coordinator (CRC) to oversee clinical trials per study protocols, GCP guidelines, and regulatory requirements. You will recruit participants, document data, and safeguard safety and data integrity.

You will coordinate day-to-day study activities, ensure protocol compliance, obtain informed consent, schedule visits, maintain regulatory files, and support sponsor visits and inspections in hospital and research settings.