Axsendo Clinical Research
Clinical Research Coordinator II
Axsendo Clinical Research, Oregon, Illinois, United States, 61061
Axsendo Clinical Research is a rapidly growing, multi‑market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Portland site is expanding and we are seeking a skilled, service‑mindful 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
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
Seniority level
Entry level
Employment type
Part‑time
Job function
Research, Analyst, and Information Technology
#J-18808-Ljbffr
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
Seniority level
Entry level
Employment type
Part‑time
Job function
Research, Analyst, and Information Technology
#J-18808-Ljbffr