Job Summary
The Clinical Research Nurse works closely with the Principal Investigator managing study conduct from study selection through study closeout. The Clinical Research Nurse is responsible for the quality and integrity of their assigned clinical studies in accordance with Good Clinical Practice (GCP) and applicable regulations.

Key Responsibilities

• Manages all aspects of a study ensuring adherence to the protocol, GCP, and applicable regulations, including participating in the informed consent process, coordinating, and performing all study visit procedures per protocol, managing Investigational Product and study related supplies and equipment, assisting with monitoring visits, attending Investigator Meetings, and assisting with query resolution, as required.
• Provides the highest level of care and excellent customer service for study participants.
• Acts as a knowledgeable clinical resource to the team.
• Ensures study drug is dispensed, accounted for and returned to the Sponsor per protocol.
• Collaborates with lab staff to plan for and manage laboratory samples throughout the length of the study, including review of the laboratory manual.
• Ensures Serious Adverse Events (SAE’s) are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) within 24 hours of site being notified of event, including collecting all required information for initial and follow-up reporting.
• Ensures visit logs and Clinical Trial Management System (CTMS) visit status are accurate and complete.
• Facilitates ongoing Quality Assurance (QA) review of studies, in collaboration with the Clinical Data & QA department, including assisting with risk assessments, root cause analysis, and development of corrective and preventative actions as applicable.P
• Performs additional duties and projects as assigned

Qualifications

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical, record keeping and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with MS Office and other related software.

Education and Experience

• BSN, RN required.
• At least two years’ experience in clinical research setting preferred.
• CCRC preferred.

Salary

• $85-90K