Research Nurse
Location: Baltimore Maryland
Description: Johns Hopkins University is currently seeking to employ Research Nurse right now, this vacancy will be placed in Maryland. For detail informations about this vacancy opportunity kindly see the descriptions. The employee will assume a position in the Division of Clinical Pharmacology Drug Development Unit as a Research Coordinator conducting clinical studies sponsored by pharmaceutical companies, govern! ment agencies, and Johns Hopkins investigators. Subject populations involved in the studies include healthy adults and various populations with disease.
General Summary-The person in this position will: Work on multiple complex clinical studies which require a high level of knowledge, coordination and data abstraction. Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, transmit/distribute protocol information as needed, and administer medications as prescribed under orders of an authorized prescriber. Interact with faculty, fellows, and staff of various divisions and departments of the Johns Hopkins School of Medicine.
Essential Job Functions: The person on this position will:
Understand and adhere to schedules, protocols, and Standard Operating Procedures (SOP). Communicate with others in the DDU and the division to express ideas, make suggestio! ns, seek help as necessary, and to work as part of a team. Com! plete and maintain up to date documentation of human subjects’ research training required by the JHM IRB, DDU, and protocol Sponsors including and not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR. Attend and participate in weekly staff and division meetings, protocol and research related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned. Assist investigators in defining information and plans required to accomplish goals of the clinical trials. Prepare essential documents and maintain a binder and data base of IRB submissions for protocol initiations, annual renewals, further study actions, adverse events, and progress reports according to IRB and sponsor requirements. Develop and maintain a protocol database and spreadsheets for tracking patient activity, financial management and data analysis. Prepare and maintain study specific data base and documents for research cha! rts e.g. source documents and case report forms when these are not supplied by a sponsor. Perform subject recruitment; develop advertising and recruitment materials, post flyers, and place advertisements in newspapers, websites, or other venues as determined by study team. Inform potential study subjects about research studies, procedures, and protocol requirements. Explain the informed consent process to subjects, obtain, and document subject informed consent. Conduct screening interviews and administer screening questionnaires. Collect study required data from patients, charts, electronic databases, clinical and research laboratories, imaging services and other sources. Assess eligibility of potential study subjects comparing patient history and clinical laboratory results with study specific inclusion and exclusion criteria. Enroll eligible subjects into studies and provide eligibility source documentation for all patients enrolled in the study. Maintain study subject ro! sters to track and document status of subjects and complete screening, ! enrollment, completion, dropout, and termination information reports. Provide patient education as needed to enhance subject safety and compliance with study. Prepare nursing orders and perform protocol-specific in-service training for nursing staff and scheduled admissions on the inpatient Clinical Research Unit (CRU Osler 5). Order and inventory clinical supplies necessary for performance of studies. Assemble PK kits and admission documentation to be supplied for inpatient CRU study visits. Schedule subjects for admissions, appointments, tests, and follow-up visits at the appropriate time to assure completion of protocol requirements.
Coordinate and complete subject study visits according to study protocol to include vital signs, ECGs, phlebotomy, obtaining clinical samples, performing health assessments, and administering medications per hospital policy. Design and compile materials which aid physicians and other staff in complying with protocol requirements for! these visits and tests. Collect, compile, and maintain data in a research chart for each patient from a variety of sources. Organize and enter subject and protocol data into DDU Volunteer, study roster, and other databases. Communicate with laboratories or investigators regarding laboratory findings. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Monitor to confirm accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about study issues. Respond in a time! ly manner to special projects or queries related to the data. Manage an! d document subject remuneration per IRB approved protocol specific plan and DDU SOP. Oversee personnel who may be assisting with any of the above duties. Meet regularly with Principal Investigator, Associate Director, or Research Manager to review data accuracy and overall study progress. Prepare reports on individual patients and descriptive statistics for the protocol as required by the Principal Investigator or Sponsor. Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Meet with clinical trial financial management staff as needed to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract. Participate in relevant DDU, protocol, sponsor, and Clinical Pharmacology meetings as required to remain current and increase knowledge of clinical trials. Be willing and available for travel to research and study related meetings if deeme! d necessary by the PI. Be available to work evenings and/or weekends per study requirements if scheduled in advance. Additional duties may be required that are not yet identified.
Scope of Responsibility: Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the DDU and its potential impact on the working unit. Will be responsible for own work. Decision Making: Demonstrate an ability to work well with a diverse professional team and with minimal supervision. Exercise professional judgment and assume responsibility for own decisions, actions, results and consequences. Authority: Will report to the Research Manager in the Drug Development Unit (DDU). Will indirectly supervise ICTR Clinical Research Unit nurses and dietitians working with subjects and laboratory personnel processing subject samples. Communication: The person in this position ! will be expected to exchange complex and detailed information in an app! ropriate manner requiring strong oral and written communication skills.
Qualifications:
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred. Certification as a SOCRA or ACRP Clinical Research Coordinator preferred. Current CPR certification required. Must maintain current licensure and certification during duration of employment. Successful completion of the JHH credentialing process is required prior to start date.
Additional Competencies: Proven experience and successful work history in a comparable clinical trials research environment. Knowledgeable of and compliant with the Code of Federal Regulations Title 21-Good Clinical Practice Parts, 11, 50, 54, 56, and 312; with the International Conference on Harmonisation Good Clinical Practice Guideline (E6); and with the policies and guidelines of the Johns Hopkins medicine IRB, and ! SOPs of the DDU and clinical trial sponsors. Phlebotomy skills. Demonstrated organizational and time management skills with a high degree of attention to detail. Ability to manage multiple and competing priorities. Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.
Physical Requirements: Occasionally lifting, carrying objects weighing 20 lbs. or less. Occasionally pushing, pulling objects weighing 20 lbs. or less.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
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This vacancy starts available on: Sat, 12 Oct 2013 05:11:40 GMT