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We are currently seeking a Sr. Research Nurse to implement and oversee multiple, single-center and multi-site national studies as assigned for the division of Transplant Oncology and Infectious Disease (TOID). Our primary research is related to the use of novel organ sources to address the national organ shortage, such as HIV+ to HIV+ transplant under the HOPE Act. The Sr. Research Nurse should be someone who works well in a fast-paced collaborative atmosphere but can also maintain a high degree of independence. This position will report directly to the TOID Research Nurse Manager, Operational Manager, and Principal Investigator.
DUTIES AND RESPONSIBILITIES
Project Management
Pre-study
- Anticipates research requirements for designated patient populations.
- Collaborates in development & writing of protocols and consent forms, as appropriate.
- Collaborates in the development and preparation of regulatory documents as appropriate
- Applies knowledge of study design to evaluate new protocols.
- Applies knowledge of federal & local regulations when evaluating new protocols.
- Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc., for assigned protocols.
- Collaborates in the determination of roles & responsibilities of research team members in the implementation of assigned trials.
- Evaluates the impact on & availability of resources for assigned clinical trials.
- Lists & clarifies concerns & questions about new protocols with Research Nurse Manager and PI. Proposes & negotiates alternatives to improve protocol implementation.
Pre-initiation
- Collaborates in the design of appropriate methods for the collection of data required for assigned trials.
- Oversees & collaborates in development of study tools, including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable).
- Develops study-specific CRFs.
- Participates in the development of study-specific databases, assuring clinical data is appropriate for answering study-specific endpoints.
- Develops study-specific laboratory and operational manuals.
- Oversees that regulatory requirements are met for designated studies.
- Assures compliance with local, national, and international regulatory standards; as appropriate, prepares & submits required regulatory documents.
- Develop training materials for assigned studies/projects.
- Monitors for and notifies PI of IRB approval/request for further information as appropriate.
- Determines that IRB approval has been received before initiation of research activity.
- Represents the department at research and protocol initiation meetings.
- Assures that all elements of a trial are in place before activating sites.
- Participates in communications with protocol sponsors, NCI, and the cooperative group and coordinates plans to address issues with the PI.
Recruitment & enrollment
- Responsible for evaluating and assuring recruitment and study/project goals are met by the research team and participating sites.
- Responsible for the development of recruitment strategies to ensure patient accrual within protocol timeframes.
- Prepares and presents study-specific updates to Research Nurse Manager, Operations Manager, and Investigators as requested. Identify and provide recommendations to remediate issues of concern.
Data Management/Document maintenance
- Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
- Applies clinical/pharmacological knowledge to ensure that safety reporting processes for assigned studies are implemented and maintained.
- 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 external sites' compliance with required study procedures & GCP standards.
- Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & response.
- Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process).
- Participates in sponsor/cooperative group/internal audits/monitoring.
- Assists with development & review of TOID SOPs for the performance of clinical research.
- Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.
Staff Education
- Participates in the orientation process for new Clinical Research Nurses and Clinical Research Coordinators, including the mentoring and management of other clinic personnel to promote quality, safety, and excellence in care.
- Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process.
- Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development.
Other
- Collaborates with other members of the research team in preparing study results for presentation/publication.
- Authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise.
- Identifies nursing research questions related to protocol populations/issues and, with assistance, collaboration, and appropriate financial support, implements nursing research within departmental priorities.
- Takes advantage of opportunities to make presentations in the local community regarding research projects, areas of expertise, etc.
Minimum Qualifications
- Individual must be a registered nurse, licensed in the State of Maryland
- Minimum of two years of experience in the specialty or a related area required.
Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $38.51 - $67.53 HRLY ($80,000 targeted; Commensurate w/exp.)
Employee group: Casual / On Call
Schedule: flexible
FLSA Status: Exempt
Location: Remote
Department name: SOM DOM Infectious Disease
Personnel area: School of Medicine
