Research Nurse

About the role

CentraState Healthcare System, based in Freehold, New Jersey, is a leading nonprofit healthcare provider dedicated to serving the community. Its comprehensive network includes CentraState Medical Center, a community-focused hospital, an ambulatory campus, two senior living facilities, three free-standing community health pavilions, and a charitable foundation. As the third-largest employer in Monmouth County, CentraState has earned repeated recognition as a Great Place to Work-Certified™ company, reinforcing its reputation as an exceptional workplace.

Responsibilities

• Ensures study is compliance with local and federal laws and regulations.
• Study Implementation: Ensures activation and training activities have occurred. Presented at the appropriate committee meetings (if department required). Communicates all protocol requirements with the healthcare team. Obtains documentation of such training and communication.
• Ensures study related activities are conducted per protocol and SOPs. Develops and completes all source documentation forms as required.
• Recruitment and Enrollment: Ensures the recruitment of subjects for study participation; coordinates screening of subjects, performs intake assessments, and ensures inclusion and exclusion criteria are met. Consents patient and ensures proper consent process documentation. Enrolls subjects through the relevant system (IVRS/OPEN, etc).
• Creates and / or maintains proper documentation for study activities. Ensures the correct treatment plans, medications and modifications are complete and accurate. All dose adjustments are allowed per protocol. Acts as a liaison between sponsor and physician to ensure all protocol activities, medications and decisions are made per protocol. Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress.
• Quality and Compliance: Performs and oversees data collection and documentation in compliance with SOPs and GCPs. Facilitates/collaborates with regulatory staff on informed consent document, internal SAE reporting and protocol deviations; demonstrates proper management of adverse events. Manages budget and billing process and assists in the development of specific budget for each protocol with PI.
• Patient Care Activities: Performing assessments and other duties within the nursing scope of practice in accordance with protocol requirements. Demonstrates appropriate sample management activities to ensure the integrity of all biological samples; Manages or oversees the inventory of equipment and supplies related to the study and orders more as needed.
• Other duties as assigned

Qualifications

• Bachelor's Degree in Nursing required, MSN or PhD preferred.
• 1-2 years of research experience as an RN required.
• Current Oncology experience preferred.
• Current NJ RN license required.
• SOCRA or ACRP certification preferred.
• Excellent attention to detail and ability to keep detailed and accurate records.
• Strong professional, organizational, and interpersonal skills to effectively relate with all members of the healthcare team