We are seeking a Sr. Research Nurse who will report to the Principal Investigator(s), Research Nurse Manager, and Lead Research Nurse. This position is responsible for the coordination and implementation of assigned clinical trials within the Developmental Therapeutics Program.



Specific Duties & Responsibilities



Project Management

Pre-study
Anticipates research requirements for designated patient populations.
May collaborate in the 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.
Evaluate the impact on & availability of resources for assigned clinical trials.
Lists & clarifies concerns & questions about new protocols with PI &/or sponsor.
Proposes & negotiates alternatives to improve protocol implementation.


Pre-initiation

Collaborates in the determination of roles & responsibilities of healthcare team members in the implementation of assigned trials.
Collaborates in the design of appropriate methods for collecting data required for assigned trials.
Oversees & collaborates in the development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable).
Assures receipt of a protocol by the pharmacy for review & input as appropriate.
Assures compliance with local & national regulatory standards.
Collaborates with the study team and pharmacy to prepare drug data sheets for new trials.
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 opening to accrual.
Communicates with protocol sponsors, NCI, and cooperative groups, and coordinates plans to address issues with PI.
Works with CBT on beacon protocol order sets before start-up and attends institutional PORSCHE meetings to approve electronic order sets.


Recruitment & enrollment

Ensures initial & 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 & external sources & monitors compliance with requirements of assigned clinical trials.
Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to the study drug/procedure.
Manages patients on clinical studies while adhering to all protocol mandates and standard of care clinical practice.
Assures all clinical protocol deviations are communicated with the team for proper documentation and or submission to regulatory agencies.
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.
Works with CBT on beacon protocol order set changes with amendments that require adjustment to the original order set plan.
Quality Assurance


Evaluates outcomes of clinical trials.

Monitors study team compliance with required study procedures & GCP standards.
Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & responses.
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 the development & review of institutional SOPs about the performance of clinical research.
Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.


Communication

Independently/collaboratively performs responsibilities of Level I
Collaborate closely with the study coordinator on patient updates and clinical issues to ensure prompt, accurate reporting to sponsors or other entities is handled within protocol/ regulatory guidelines.


Education

Patient/Family Education
Provides initial and ongoing education to patients and families regarding pertinent clinical trial and clinical management issues.


Staff Education

Participates in the orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting.
Coordinates and/or presents continuing education/in-service programs for clinical team/outpatient treatment nurses and or phlebotomy staff as appropriate.
Attends and participates in in-service and external training, workshops, conferences, and other relevant programs for professional growth and development as relevant.


Community

Collaborates with other members of the research team in preparing study results for presentation/publication.
Given opportunities, authors/coauthors manuscripts for publication in the nursing literature and/or presentations 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.


Clinical Practice

Planning
Identifies needs and incorporates information from other health care disciplines into a clinical research protocol.
Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations.


Implementation

Collaborates with the health care team to coordinate and facilitate protocol requirements for assigned clinical trials.


Evaluation

Evaluate the effectiveness of nursing care planned, administered, or delegated.
Evaluate patients' response to interventions outlined in study protocol; propose alternative methods to meet individual patient needs.
Evaluate the effectiveness of nursing care planned on a long-term basis.
Gives rationale for action/inaction based on scientific principles, practice experience, and internal/external regulations.
Evaluate patients' participation in assigned clinical trials and identify barriers to compliance.
Plans, proposes, and evaluates means to overcome identified barriers to protocol compliance.


Consultation

Develops and maintains collaborative relationships with members of other healthcare disciplines to facilitate clinical and research outcomes.
Provides guidance and direction to other healthcare professionals (internal and external) in the implementation of research protocols.
Evaluate the effectiveness of collaborative roles with other health care professionals.


Clinical Responsibilities

Perform clinical duties as assigned.


Supervisory Responsibilities

Provides supervision and oversight of Clinical Associates as assigned.


Working Conditions

Possible exposure to communicable diseases, hazardous materials, radiation, and pharmacologic agents.
Safety regulations must be followed.
Work schedules are determined by protocol activity and may demand flexible and/or extended work hours.


Minimum 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.
Minimum of two year's experience in the specialty or a related area.
Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience.