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Posted: Wednesday, July 5, 2017 11:52 AM

The Department of Oncology is seeking a Senior Research Nurse. The Sr. Research Nurse is responsible for the coordination and implementation of assigned clinical trials within the research program.Duties and Responsibilities:Project Management:Pre:study:Anticipates research requirements for designated patient populations. May collaborate in development and writing of protocols and consent forms, as appropriate. Collaborates in development and preparation of regulatory documents as appropriate. Applies knowledge of study design to evaluate new protocols. Applies knowledge of federal and local regulations when evaluating new protocols. Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. Evaluates the impact on and availability of resources for assigned clinical trials. Lists and clarifies concerns and questions about new protocols with PI and /or sponsor. Proposes and negotiates alternatives to improve protocol implementation.Pre:initiation: Collaborates in the determination of roles and responsibilities of health care team members in the implementation of assigned trials. Collaborates in the design of appropriate methods for collection of data required for assigned trials. Oversees and collaborates in development of study tools including data collection forms, eligibility checklists, pre:printed orders, and distribution of the protocol on the Web Library and Internet (where applicable). Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate. Provides copy of study and pre:printed data forms to Data Management office for review and approval as appropriate. Prepares GCRC and PCRU protocol submissions as appropriate. Assures receipt of protocol by pharmacy for review and input as appropriate. Communicates with coordinating center and provides necessary documentation (i.e., CVs, 1572, lab licenses, normal values, IRB submissions, etc.) as appropriate.Assures compliance with local and national regulatory standards; as appropriate, prepares and submits required regulatory documents. Prepares drug data sheets for pharmacy and assures submission of same to CRO/IRB for assigned protocols as appropriate. Monitors for and notifies PI of IRB approval/request for further information as appropriate. Determines that IRB approval has been received prior to initiation of research activity. Represents department at research and protocol initiation meetings. Assures that all elements of a trial are in place before opening to accrual. Communicates with protocol sponsors, NCI, cooperative group and coordinates plans to address issues with PI.Recruitment and Enrollment:Ensures initial and ongoing eligibility of all subjects for assigned research studies: Same as Level I. Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes. Data collection/Document maintenance: Ensures collection of pertinent data from internal and external sources and monitors compliance with requirements of assigned clinical trials. Applies pharmacological knowledge to assist the investigator in determining adverse event causality and relationship to study drug/procedure. Records and documents protocol deviations. Prepares and submits protocol amendments and revisions as appropriate. Demonstrates ability to manage multiple projects at different stages of the clinical research process. Demonstrates ability to integrate new clinical trials with current research activity. Quality Assurance: Evaluates outcomes of clinical trials. Monitors study team compliance with required study procedures and GCP standards. Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, and response. Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process). Participates in sponsor/cooperative group/internal audits/m


• Location: Baltimore

• Post ID: 24070658 baltimore is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017