Clinical Research Coordinator II - Full-time / Part-time

Clinical Research Coordinator II
Location: Houston, Texas (Full-Time, On-Site)

About Axsendo Clinical Research
Axsendo Clinical Research is a rapidly growing, multi-market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Houston site is expanding and we are seeking a skilled, service-minded Clinical Research Coordinator II to join our team. This role is ideal for experienced coordinators who can independently execute study visits, support study startup, maintain high-quality documentation, and contribute to a best-in-class patient and sponsor experience.

Position Overview
The Clinical Research Coordinator II manages the day-to-day execution of assigned clinical trials with a high level of autonomy. This includes conducting study visits, supporting investigators, ensuring protocol compliance, maintaining audit-ready documentation, and collaborating with sponsors/CROs. The ideal candidate has strong operational discipline, excellent patient communication skills, and the ability to execute visits with speed, accuracy, and professionalism.

Key Responsibilities

Patient & Protocol Management
• Independently conduct study visits, including consenting, assessments, vital signs, questionnaires, sample collection, and follow-up
• Read, interpret, and maintain full working knowledge of assigned research protocols
• Conduct pre-screening and EMR-based feasibility reviews to identify eligible candidate patients
• Coordinate eligibility discussions with the Principal Investigator
• Obtain and document informed consent in accordance with ICH-GCP and site SOPs
• Prevent out-of-window procedures and ensure all required assessments occur per protocol schedule

Safety & Regulatory Compliance
• Report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the IRB and sponsor as required
• Maintain complete, accurate, and ALCOA-compliant source documentation
• Ensure accurate Investigational Product (IP) management and accountability
• Collect and process laboratory specimens per protocol, including preparing shipments and completing lab documentation
• Maintain up-to-date temperature logs, accountability logs, and essential documentation

Data & Documentation Excellence
• Complete timely and accurate EDC entries and resolve queries promptly
• Understand and accurately use all study-related data collection instruments
• Ensure all Case Report Forms (CRFs) and patient tracking logs are complete and accurate
• Maintain audit-ready source, regulatory, and IP documentation at all times

Monitoring & Sponsor Interaction
• Prepare for monitoring visits by organizing source documents, resolving outstanding action items, and addressing prior queries
• Support monitors during visits and coordinate any required follow-up
• Maintain consistent communication with sponsors and CROs regarding data, queries, and operational needs

Operational Coordination
• Plan and prepare subject visits, coordinating room availability, equipment, and supplies
• Work closely with site administration to ensure clinic readiness
• Collaborate with investigators, sub-investigators, and cross-functional team members to support seamless study execution

Qualifications
• Minimum 1–2 years of direct clinical research experience required
• Demonstrated ability to independently conduct study visits and manage multiple protocols
• Strong understanding of ICH-GCP, safety reporting, sample handling, and data quality standards
• Experience with EMR, EDC, CTMS, and electronic source systems
• Strong communication skills and a service-oriented, patient-centered mindset
• Superior organizational skills with the ability to manage multiple competing priorities
• Ability to remain calm, timely, and precise during high-volume or fast-paced clinic days

Preferred Qualifications
• Phlebotomy and EKG training
• Certified Medical Assistant (CMA) or clinical credential
• Medical terminology proficiency
• Bilingual (Spanish/English) a strong plus
• Experience in cardiology, neurology, metabolic disease, or device trials

Why Join Axsendo
• Opportunity to contribute to a growing research organization with expanding multi-market operations
• Exposure to diverse therapeutic areas and complex study portfolios
• A supportive team culture centered around excellence, integrity, and professional growth
• Continued training and advancement opportunities within Axsendo’s clinical operations pathway