Clinical Research Nurse Coordinator I

About the role

ERA Health Research is seeking a Clinical Research Nurse Coordinator I at our Redmond, WA location. The Clinical Research Nurse Coordinator I coordinates all aspects of clinical trials, ensuring that trials are conducted according to ethical, regulatory, and scientific standards while maintaining participant safety and data integrity.

Relocation assistance is not available for this position; any relocation expenses will be the responsibility of the selected candidate.

Responsibilities

• Identify objectives, endpoints and outcome measures for a given clinical trial.
• Implement protocol and any protocol amendments according to GCP, verifying that only IRB/IEC approved versions of study documents are being used.
• Schedule, coordinate, and prepare documents, equipment, facilities for site initiation visits.
• Complete training and interpret a study implementation plan for relevant items that impact the tasks and activities the coordinator should prioritize for a given trial.
• Ensure consistency between the sites’ standard operating procedures (SOPs) and the study requirements.
• Identify all study supplies needed for a given clinical trial, assess and reconcile inventory to ensure adequate supplies throughout the trial.
• Develop and organize trial management tools such as subject study calendar, source documents, and retention materials to enhance subject compliance.
• Complete pre-screening, screening and enrolment logs and forms in an accurate and timely manner.
• Coordinate with regulatory, recruitment, and clinical staff to schedule patient visits.
• Complete informed consent and randomization of subjects accurately and according to the protocol and SOPs to ensure appropriate inclusion of subjects.
• Support and manage investigational product, including labeling, preparing and dispensing.
• Perform nursing assessments and conduct protocol-related procedures (vitals, ECGs, IV starts, infusions, pharmacokinetic sampling, etc.).
• Administer investigational products (drugs, devices, biologics) per protocol, monitor patient responses, and provide clinical care as appropriate.
• Assess, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI and sponsor.
• Manage, educate and communicate with subjects throughout the trial, including providing patient education and communicating about compliance with the visit schedule, protocol procedures, diary completion, and discontinuation.
• Complete study communications, comments, and logs in an accurate and timely manner, including basic clinical data entry into Electronic Data Capture (EDC) systems