Clinical Research Coordinator III

Clinical Research Coordinator III

Location: Houston, Texas (Full-Time, On-Site)

Department: Clinical Operations

Reports To: Site Director / VP of Clinical Operations & Site Enablement

About Axsendo Clinical Research

Axsendo Clinical Research is a rapidly expanding, multi-market clinical research network supporting studies in Pain Management, Pulmonary Medicine, Cardiovascular Disease, Wound Care, Neurology, Metabolic Disease, and Medical Devices. Our Houston site is a high-priority location with a strong pipeline of complex and specialty trials. We are seeking an experienced Clinical Research Coordinator III to lead advanced study execution, mentor junior staff, and support high-quality enrollment and patient care across our therapeutic focus areas.

Position Overview

The Clinical Research Coordinator III (CRC III) is a senior-level role responsible for independently managing complex clinical trials with an emphasis on pain management, respiratory/pulmonary studies, cardiovascular research, and wound care protocols. The CRC III executes high-acuity visits, ensures exceptional documentation standards, supports investigators, and serves as a lead coordinator for challenging or high-volume studies. This role also provides mentorship, quality oversight, and leadership support to the entire Houston site.

Key Responsibilities

Advanced Study Execution

• Independently conduct complex and high-acuity study visits, including consenting, advanced assessments, sample handling, EKGs, respiratory testing, wound evaluations, pain scoring instruments, and device-related procedures
• Serve as the lead coordinator for pain management, pulmonary, cardiovascular, and wound care trials, ensuring deep protocol familiarity and operational readiness
• Conduct thorough prescreening, EMR review, and eligibility assessments for specialty studies
• Anticipate visit requirements and prevent deviations or out-of-window procedures
• Lead study startup tasks including source development, workflow planning, and protocol-specific staff training

Data Integrity & Documentation Leadership

• Maintain audit-ready, ALCOA-compliant source documentation for all assigned studies
• Oversee data entry accuracy and supervise query resolution across complex protocols
• Identify data quality issues and collaborate with site leadership to implement corrective actions
• Support adverse event/serious adverse event documentation and reporting in high-risk therapeutic areas

Sponsor, CRO, and Monitor Engagement

• Act as the primary site contact for IMVs, SQVs, SIVs, and COVs for specialty trials
• Prepare advanced study documentation and ensure timely follow-up on monitor findings
• Communicate proactively with sponsors, CROs, and clinical project teams regarding enrollment progress, data queries, and operational challenges

Mentorship & Internal Leadership

• Provide day-to-day support, training, and workflow guidance to CRC I and CRC II team members
• Review junior staff documentation for completeness, GCP alignment, and accuracy
• Support the Site Director in promoting consistency, quality, and compliance across the Houston location
• Assist with onboarding new coordinators and supporting the development of SOPs, checklists, and best practices

Operational & Clinical Collaboration

• Work closely with Principal Investigators and Sub-Investigators to ensure high-quality patient care and protocol adherence
• Partner with clinic administration to prepare rooms, equipment, and resources for specialty visits (respiratory tests, wound evaluations, cardiovascular assessments, pain-related procedures)
• Support high-volume clinic days and troubleshoot operational issues as they arise

Regulatory, Safety & GCP Compliance

• Ensure strict adherence to ICH-GCP, FDA regulations, and internal SOPs
• Accurately document and escalate AEs/SAEs, particularly in high-risk indications
• Assist in preparing documentation for audits, site inspections, and quality reviews
• Support tracking of protocol deviations, CAPAs, and quality performance indicators

Qualifications

Required

• Minimum 3–5 years of direct clinical research experience, including complex and high-acuity trials
• Prior hands-on experience in pain management, pulmonary/respiratory studies, cardiovascular trials, or wound care research
• Ability to independently execute all study visit procedures and manage multiple protocols simultaneously
• Strong comprehension of ICH-GCP, regulatory expectations, and clinical operations workflows
• Experience engaging with monitors and supporting all types of monitoring visits
• Strong documentation skills with excellent attention to detail
• High emotional intelligence and strong patient communication skills
• Proven ability to mentor junior coordinators and support site-wide operational consistency

Preferred

• Phlebotomy and EKG experience
• Experience with respiratory testing, wound assessments, or pain scoring tools
• Medical credential (CMA, EMT, LVN, RN) preferred but not required
• Bilingual (Spanish/English) highly valuable in Houston market

Why Join Axsendo

• Senior clinical role supporting some of Houston's most impactful therapeutic studies
• Opportunity to lead complex trials in pain, respiratory, cardiovascular, and wound care
• Growth pathway into Lead Coordinator, Site Director, or Regional Operations roles
• Supportive leadership and a culture focused on service, integrity, and operational excellence
• Access to new studies, advanced training, and continuing education opportunities

Compensation

Competitive compensation commensurate with experience, plus benefits after eligibility period.