Research - Laboratory/Non-Laboratory, Staff/Administrative
General Job Description: Reporting to the Principal Investigator(s) and to the Program Manager, this position is responsible for the coordination and implementation of assigned clinical trials within the research program.
Specific Duties and Responsibilities:
A. Project Management
1. Pre-study: Anticipates research requirements for designated patient populations
May collaborate in development & 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 & local regulations when evaluating new protocols
Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
Evaluates 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
Collaborates in the determination of roles & 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 & 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)
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 & 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 & national regulatory standards; as appropriate, prepares & 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
3. 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
4. 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 study drug/procedure
Records & 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
5. 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, & 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 institutional SOPs pertaining to performance of clinical research
Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.
Independently/collaboratively performs responsibilities of Level I
1. Patient/Family Education
Designs/coordinates educational programs for patients and families relevant to protocols
Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues
2. Staff Education
Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and preceptoring
Coordinates and/or presents continuing education/inservice programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process
Attends and participates in inservice and external trainings, workshops, conferences, and other relevant programs for professional growth and development
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 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 local community regarding research projects, areas of expertise, etc.
C. Clinical Practice
Identifies need and incorporates information from other health care disciplines into clinical research protocol
Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations
Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials
3. Evaluation: Evaluates the effectiveness of nursing care s/he has planned, administered, or delegated
Evaluates patient=s response to interventions outlined on study protocol; proposes alternative methods to meet individual patient needs;
Evaluates 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
Evaluates patients= participation in assigned clinical trials and identifies barriers to compliance
Plans, proposes and evaluates means to overcome identified barriers to protocol compliance
Develops and maintains collaborative relationships with members of other health care disciplines in order to facilitate clinical and research outcomes
Provides guidance and direction to other health care professionals (internal and external) in implementation of research protocols
Evaluates effectiveness of collaborative role with other health care professionals
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing.
Bachelor's degree in nursing or related discipline required. Master's degree strongly preferred.
Minimum of two years experience in the specialty or a related area required
Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience.
Key skills, knowledge and abilities:
Demonstrated knowledge of computer applications and databases and of personal computer systems is highly desirable.
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served.
Demonstrate knowledge of the principles of growth and development over the lifespan and possess the ability to assess data reflective of the patient(s) requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.
Knowledge of investigational therapies which require special expertise and clinical care management.
Highly effective verbal and written communication skills are required.
Classified Title: Sr. Research Nurse Working Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805 - $83,865; commensurate with experience Employee group: Full Time Schedule: M-F 8:30am- 5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002940-Cancer Immunology/GI Clinical Research Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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