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:;

• Manage 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.
• Provide the highest level of care and excellent customer service for study participants.
• Act as a knowledgeable clinical resource to the team.
• Ensure study drug is dispensed, accounted for and returned to the Sponsor per protocol.
• Collaborate with lab staff to plan for and manage laboratory samples throughout the length of the study, including review of the laboratory manual.
• Ensure 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.
• Ensure visit logs and Clinical Trial Management System (CTMS) visit status are accurate and complete.
• Facilitate ongoing Quality Assurance (QA) review of studies, in collaboration with the QA department, including assisting with risk assessments, root cause analysis, and development of corrective and preventative actions as applicable.

Qualifications:

• BSN, RN degree required
• At least two years’ experience in clinical research setting required
• CCRC preferred
• 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 and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced environment