Axsendo Clinical Research · 1 month ago
Clinical Research Coordinator III
Houston, Texas, United States
Full-time
Onsite
Mid, Senior Level
3+ years expAxsendo Clinical Research is a rapidly expanding clinical research network supporting studies in various therapeutic areas. They 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 their focus areas.
BiotechnologyClinical TrialsMedical DeviceTherapeutics
Responsibilities
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
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
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
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
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
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
Qualification
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
Benefits
Competitive compensation commensurate with experience, plus benefits after eligibility period.
Company
Axsendo Clinical Research
Axsendo Clinical Research is a biotechnology firm that provides therapeutics, drug, and device research services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Tiffany Hill
Founder & CEO
Company data provided by crunchbase