Clinical Research Coordinator in , AZ

Overview

Advancing Care Through Innovation. The position is on-site Monday - Friday in Surprise, AZ. Address:
Southwest Kidney Institute, PLC 14671 W. Mountain View Blvd, Suite 112 Surprise AZ, 85374. Learn more about Panoramic Science at:

Clinical Research Coordinator I will perform delegated duties such as protocol-required visit procedures, administering questionnaires and subject material, administering and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator will engage with Principal Investigators, pharmaceutical companies (Sponsors), contract research organizations (monitors), and research subjects.

• Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study.
• Drive enrollment to meet contractual targets:
  Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (Attributable, Legible, Contemporaneous, Original and Accurate).
• Prepare for monitoring visits:
  All Source Documents organized and readily available. All outstanding items from prior monitoring visit resolved. No open queries from prior visit. Temperature and accountability logs readily available.
• Ongoing study oversight and management:
  Plan subject visits according to protocol-specific visit schedule. Avoid protocol deviations due to out-of-window procedures. Communicate with location administration to ensure space and resources are available as needed. Report Adverse and Serious Adverse Events to IRB and Sponsor per reporting guidelines. Dispense/collect study medication and provide accurate Investigational Product accountability. Collect and process subject laboratory specimens according to protocol. Complete case report forms (CRFs) and other patient tracking information accurately and on a timely basis.
  
  Maintain thorough understanding of all data collection instruments and collect data accurately according to protocol.
• Perform other duties as required, assigned, or requested.

• Bachelor’s degree required;
  Nursing or Health Science preferred.
• Bilingual preferred (Spanish).
• Minimum 2 years’ experience as a clinical research coordinator.
• Therapeutic area experience in CKD, nephrology, or vascular access a plus.
• Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations.
• Must be able to perform basic clinical procedures such as: blood work, vitals, height, weight, etc.
• Must be able to perform an ECG.
• Travel to Investigator meetings or other study locations is expected with this position; travel may be outside the local area and overnight.

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