RN, Clinical Research

The RN, Clinical Research executes and coordinates daily clinical research activities according to GCP and FDA/ICH guidelines; reviews and assists in the selection of Sponsor supported clinical trials; completes and organizes all IRB/Sponsor regulatory documents; negotiates clinical trial budgets and invoices for site activities; ensures IRB approved protocols are implemented and followed; educates patients and their families about clinical trial treatments and possible side effects; executes and documents the informed consent process and monitors patient status and safety; collects, organizes and reports research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; conducts visits with CRAs (Clinical Research Associates) to initiate protocols and to verify source documents; maintains investigational product inventory and oversees the dispensing of investigational product to patients; reports regularly to the Principle Investigator on the status of all open clinical trials under his/her supervision.

Works closely with the laboratory to ensure samples are collect and processed according to protocol.

JOB SPECIFIC DUTIES AND RESPONSIBILITIES: Under direct supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.Collaborates with physicians in determining eligibility of patients for clinical trials.Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.Screens potential patients for protocol eligibility.

Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.Coordinates patient care in compliance with protocol requirements.

May disburse investigational drug and provide patient teaching regarding administration.

Maintains investigational drug accountability.In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.Responsible for accurate and timely data collection, documentation, entry, and reporting.

Schedules and participates in monitoring and auditing activities.Maintains regulatory documents in accordance with SOPs and applicable regulations.Participates in required training and education programs.

Responsible for education of clinic staff regarding clinical research.Additional responsibilities may include working directly with other research bases and/or sponsors.Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.Interacts with the Clinical Trial Sponsors to...