Job Description
As a Clinical Research Nurse, you are at the forefront of initiating nursing activities in accordance with ICH GCP guidelines.
Key Responsibilities:
- Execution of Study Procedures:
- Diligently execute study protocols and procedures as delegated.
- Collect data in source documents for all participant visits as specified in delegation.
- Handle general administrative tasks related to clinical trials, such as scheduling patient visits.
- Maintain patient tracking systems and provide relevant metrics.
- Ensure timely ordering of study-specific supplies and maintain adequate stock.
- Patient Interaction and Clinical Activities:
- Greet and ease participants, ensuring their comfort.
- Facilitate participant understanding of procedures and tests.
- Ensure all examinations align with the study protocol.
- Optimize patient recruitment efforts, fostering participation.
- Support the Principal Investigator (PI) and Co-Investigators during patient visits.
- Foster patient retention and encourage compliance with study visits.
- Data Collection and Quality Assurance:
- Collect vital signs, including height, weight, and BP.
- Perform delegated phlebotomy procedures.
- Assist in maintaining medical equipment.
- Liaise with external clients when necessary.
- Prepare for monitor visits and engage in sample preparation and shipment.
- Uphold meticulous records, ensuring high-quality data.
- Informed Consent Process:
- Follow Site SOPs for the Informed Consent process, ensuring participant comprehension.
- Data Integrity and Emergency Preparedness:
- Ensure completion of accurate source documents.
- Maintain impeccable patient data records.
- Validate emergency supplies and monitor expiration dates.
- Collaborate with Investigator, monitor, and data encoder for data query resolution.
This role of a Clinical Research Nurse is central to the seamless operation of clinical studies.
Skills and Requirements
Nursing