Clinical Research Coordinator II

Axsendo Clinical Research is a rapidly growing, multi‑market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Phoenix site is expanding and we are seeking a skilled, service‑mindful Clinical Research Coordinator II to join our team. 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 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 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 #J-18808-Ljbffr