Clinical Research Nurse - 246478

Looking for a strong Clinical Research Nurse to join our team!

• 5 Years of Nursing experience
• 1 year of Research Nursing experience

Core Responsibilities and Essential Functions:

Coordinates all facets of patient involvement in clinical trials. - Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines. - Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines. - Communicates with physician/office staff regarding scheduling protocol specific requirements. - Attends patient visits and gathers protocol-specific information when required. - Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate. - Coordinates dispersement of protocol provided drug therapy. - Ensures that Investigation Product chain-of-custody practices are instituted and documented. Maintains accurate records for patients enrolled on clinical trials. - Communicates effectively with Research Assistants and other research staff. - Gathers appropriate source documentation - Submits required documentation within designated time frame. - Provides proper documentation of eligibility, treatment and follow-up requirements. - Provides accurate research information to physicians and sponsors. - Maintains a current chart on each protocol patient. - Enters patient visits into clinical trial database. Ensures regulatory guidelines are followed.

Prepares research charts for monitoring visits and audits and assists with visits as required. - Follows guidelines and timelines for reporting Adverse Events and Deviations. - Maintains current protocol with revisions, amendments and current IRB approved informed consent. Ensures clinical trial and sponsor-required training is completed. - Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required. - Ensures that ongoing training during the course of a clinical trial is completed. - Facilitates ongoing training for other team members, including investigators. - Maintains current Human Research Participant Protection and Hazardous Material training. Assists with other departmental functions. - Attends committee meetings as required. - Attends functional team meetings and disseminates information. - Assists with regulatory and billing functions, when required. - Responsible for additional projects, as directed by the manager.