Intermediate (2-5 years of experience)
Summary of the Role
The Clinical Research Nurse plays a pivotal role in clinical trials and works to ensure the integrity and quality of the research while maintaining patient safety and meticulous adherence to protocol. They work closely with patients, physicians, and other healthcare professionals to administer treatments, monitor patients, and collect data for clinical research studies.
Required Skills
Excellent clinical skills and knowledge of health care related to clinical research.
Strong ability to communicate effectively with patients and the healthcare team.
Detail-oriented with strong organizational skills to manage multiple tasks concurrently.
Proficiency in using clinical trial management software and electronic health records.
Capability to maintain ethical standards and protect the rights and welfare of patients.
Qualifications
Current Registered Nurse (RN) license.
Bachelor of Science in Nursing (BSN) or equivalent degree.
2-5 years of clinical nursing experience, with prior experience in a clinical research setting preferred.
Certification in Clinical Research Nursing (CRN) is an asset.
Understanding of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
Responsibilities
Conduct patient screening and enrollment processes for clinical trials.
Administer study medications and monitor patients for adverse reactions.
Document patient progress and adverse events accurately and promptly in the clinical trial management system.
Collaborate with the research team to ensure compliance with protocol and overall clinical objectives.
Educate patients and their families about the clinical trial process and the specifics of the study.
Ensure that the informed consent process is conducted properly and all participant questions are addressed.
Manage patient follow-up and ensure all visits are completed as per the study schedule.
Coordinate with laboratory personnel to process and ship specimens accurately and in a timely manner.
Maintain strict confidentiality of patient information in compliance with HIPAA regulations.