Clinical Research Coordinator

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

Job summary

Winaxis LLC in Dallas, TX, is seeking a Clinical Research Coordinator to coordinate and manage clinical trials in line with GCP, study protocols, and regulatory requirements. The role involves participant recruitment, data collection, and ensuring safety and data integrity.

You will work with investigators, sponsors, CROs, and laboratories; handle informed consent, CRFs/EDC, and regulatory documents; monitor safety and timelines; and support monitoring visits and audits.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or related field.
• Experience in clinical research or trial coordination preferred.
• GCP certification is an advantage.

Responsibilities

• Coordinate day-to-day activities for clinical studies.
• Review study protocols for protocol compliance and regulatory requirements.
• Recruit, screen and enroll eligible participants.
• Obtain informed consent prior to procedures.
• Schedule visits and coordinate assessments and procedures.
• Collect, document, and maintain data in CRFs and EDC systems.
• Maintain essential regulatory documents and study records.
• Monitor participant safety and report adverse events promptly.
• Coordinate with Principal Investigators, sponsors, CROs, and labs.
• Prepare for sponsor monitoring visits, audits, and inspections.
• Ensure adherence to GCP and local/international regulations.
• Track timelines, recruitment targets, and protocol milestones.
• Assist with initiation, amendments, close-out, and archiving.
• Maintain confidentiality of participant information and research data.

Skills

Clinical trials

ICH-GCP

Organizational skills

Communication skills

Attention to detail

MS Office

EDC systems

Independent work

Education

Bachelor's degree in Life Sciences or related

Tools

EDC systems

MS Office

Job description

Job Summary:

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical trials in accordance with study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements. The role involves participant recruitment, study documentation, data collection, and ensuring the smooth execution of research activities while safeguarding participant safety and data integrity.

Key Responsibilities:

• Coordinate and oversee day-to-day activities related to assigned clinical studies.
• Review study protocols and ensure all trial activities are conducted in compliance with protocol requirements.
• Recruit, screen, and enroll eligible study participants according to inclusion and exclusion criteria.
• Obtain and document informed consent from study participants prior to study procedures.
• Schedule participant visits and coordinate study assessments, procedures, and follow-ups.
• Collect, document, and maintain accurate study data in Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
• Maintain essential regulatory documents, investigator site files, and study records.
• Monitor participant safety by identifying, documenting, and reporting adverse events and serious adverse events in accordance with regulatory timelines.
• Coordinate with Principal Investigators, sponsors, Contract Research Organizations (CROs), laboratory personnel, and other study stakeholders.
• Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.
• Ensure adherence to Good Clinical Practice (GCP), institutional policies, and applicable local and international regulations.
• Track study timelines, recruitment targets, and protocol milestones.
• Assist with study initiation, amendments, close-out activities, and archiving of study documents.
• Maintain confidentiality of participant information and research data at all times.

Required Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or a related healthcare field.
• Prior experience in clinical research or clinical trial coordination is preferred.
• Certification in Good Clinical Practice (GCP) is an advantage.

Required Skills:

• Strong understanding of clinical trial processes and research ethics.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Excellent organizational and time-management skills.
• Strong verbal and written communication abilities.
• Attention to detail and accuracy in documentation.
• Proficiency in Microsoft Office applications and EDC systems.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Effective problem-solving and interpersonal skills.

Working Conditions:

Work is typically performed in hospitals, research institutions, academic medical centers, or clinical research organizations. May require flexibility to accommodate participant schedules and sponsor visits.