CANDIDATES WHO MEET ANY QUALIFICATION LEVEL OUTLINED BELOW ARE ENCOURAGED TO APPLY!

Nursing Levels: Must have current or compact RN licensure in the state of North Carolina. BSN/MSN preferred.

• Overall functions: Sets up and performs routine clinical trial related activities. Collects, enters and summarizes clinical trial data. Monitor patients, their results, detects and reports all events per protocol, applicable policies and applicable regulations.
• Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH). Assures regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations.
• Communicates protocol information (through meetings, presentations, etc.) to physicians and staff. Read and understand clinical research protocols, informed consent documents and related materials. Assists in verifying patient history and medical information to assure appropriate enrollment in clinical trials. Confers with prospective study subjects to obtain informed consent as delegated by principal investigator. Schedules and attends patient visits. Perform protocol driven procedures as required and per licensure. Troubleshoots enrollment and study conduct issues. Maintains clinical and professional competency standards.
• Process: Generates study specific source documents (paper and/or electronic) for use in clinical trial data collection. Collects blood samples, cultures, tissues and other samples for processing, shipping and or analysis. Collects and process information from patient charts, medical records, interviews and appropriate forms. Assesses and reports adverse events in a timely manner. Maintains protocol defined timelines and department guidelines. Completes study specific case report forms, electronic data capture systems and assures appropriate communication with study sponsors. Arranges and attends monitoring visits. Works with Sr. team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. With leader or senior team member guidance, coordinates scheduling of pre-site, initiation, monitoring and closeout visits. Assures drug and device accountability is up to date and available at all times