Research Nurse

The Johns Hopkins University Department of Otolaryngology, Division of Research is seeking a Research Nurse to participate in studies of Otolaryngology-Head & Neck Cancer and related disorders. To assist the Program Director and Principal Investigators (PI's) in the design and implementation of novel high-profile clinical trials for new methods to treat and to follow select patients and related disorders. The successful applicant will be passionate about patient well-being and improving the long-term trajectory for those patients through research and clinical care.

The Research Nurse will work with a multidisciplinary team including physicians, research nurses, and research coordinators, applicants must be able to work and make decisions independently and have good time management skills in order to work on several projects simultaneously and meet deadlines. Will have excellent organizational skills and data management are required, as well as flexibility and a willingness to help out members of the collaborative team, when such an occasion arises.

Specific Duties & Responsibilities

General Responsibilities Include

• Work on complex clinical studies which require a high level of knowledge, coordination and data abstraction.
• Maintain good working knowledge of all assigned protocol and reporting requirements.
• Screen potential participants for participation in trials and recruitment for studies through patient registries and relevant clinics.
• Evaluate ongoing eligibility of research subjects participating in clinical trials; collaborate with principal investigator to obtain exceptions as appropriate.
• Evaluate the effectiveness of nursing care given on a short-term basis.
• Ensure the informed consent process for studies is completed, and coordinate participant enrollment and follow-up visits related to each respective study.
• Assesses and ensures subject safety throughout participation in the trial and assists patients with medical problems related to study.
• Recognizes common laboratory values and alerts appropriate individuals for clinically significant deviations.
• Presents PI with relevant information for determination of seriousness, causality, and intervention for adverse events.
• Acts on the PI’s recommendation for adverse event intervention.
• Maintain follow-up to determine resolution of adverse event.
• Will recognize and document adverse events per protocol and ensure reporting to the appropriate study and regulatory personal, as well as initiates adverse events reports and ensures proper and timely distribution to sponsor and IRB.
• Grades identified toxicities per NCI or protocol specific criteria.
• Attend medical staff meetings to review study progress.
• Responsible for appropriate documentation of clinical study in medical record and appropriate protocol documents.
• Schedules visits, tests & procedures for patients entered into clinical trials to ensure results are available in a timely manner.
• Will assist with the management of protocol related health problems and maintain communication with members of the research team in a confidential manner and in accordance with good clinical practice.
• Communicates data from clinical trials relevant to patient management to community-based health care personnel.

Research Responsibilities

• Maintaining research related documents and correspondence in a confidential manner, including informed consent forms and research data.
• Collaborate with other member of the research team to prepare for and respond to study audits.
• Will assist with the collection and management of study data and bio specimens, entering data into study database(s), as well as documenting and reporting adverse events.
• Resolving queries and reviewing monitoring reports to identify and correct errors Reporting protocol deviations and adverse events in a timely manner.
• Maintaining study inventory according to regulatory standards.
• Reviewing research accounts status with PIs.
• Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
• May participate in the development of invoicing…