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Certified Clinical Research Coordinator-rn

Mount Sinai Medical Center
Mount Sinai Health System
Type Full time Posted 6/24/2014
Salary - n/a - Starts 12/19/2014
NY - New York (All) - Manhattan Referral - n/a -    
Job Title:  Certified Clinical Research Coordinator-rn
Full/Part Time:  Full Time
Location/Affiliates:  The Mount Sinai Hospital
Department:  015 - Cancer Institute
Requisition Number:  NR13-1560124
Job Description: 



The Research Nurse works to provide and maintain comprehensive nursing care to adult cancer patients (MDS/AML) in a diverse clinical research setting. The standards of care provided to the research patient results from the ability to assess the health care needs while ensuring compliance to the requirements of the protocol. The Research Nurse collaborates with all members of the research team to effectively direct and manage all aspects of the research protocol with minimum supervision.








1. Provides direct care to the research patient utilizing the nursing process with knowledge and understanding of the purpose and methodology of the protocol.


2. Demonstrates critical nursing judgment to maintain the integrity of the research protocol without compromising patient safety.


3. Demonstrates appropriate clinical skills relating to the execution of research protocols, such as determining eligibility, exclusion criteria, identifying need for dose modifications and toxicities.


4. Demonstrates the ability to assess situations and make critical decisions affecting research procedures.


5. Documents all clinical assessments and care provided, observing any changes in a patient's status and response to the protocol.


6. Demonstrates the ability to practice independently within study guidelines.


7. Administers medication safely and with knowledge of facility policies and procedures.


8. Administers selective research medication safely with accountability and knowledge of its effect within the protocol domain and facility guidelines.


9. Performs accurate and safe procedures within the scope of MSSM nursing practice (vital sign monitoring, specimen collection, serial blood drawing via venipuncture or venous and central access intravenous lines, fluid delivery, and assisting with medical procedures.


10. Maintains effective communication at all times.


11. Educates research patients and families about the clinical study and maintaining optimal health.


12. Participates actively in the informed consent process.










1. Assists in the reviews of each protocol prior to approval at PRMC and addresses questions or concerns to the appropriate personnel (Principal Investigator, CCTO Director of the MDS/AML Program).


2. Communicates study information to all staff in facilities where study is to be implemented and ensures that copy of protocol is available on site.


3. When appropriate, creates protocol flow sheet to identify a brief summary of the protocol requirements for all staff nurses in the clinical settings where study is to be implemented.


4. Develops, implements and evaluates a plan of care for each patient incorporating short and long term goals and expected outcomes of each patient enrolled in the study.


5. Sets priorities based on patient care and protocol requirements.


6. Communicates through verbal, nonverbal, written and computer methods effectively with all members of the health care team.


7. Works with staff in a team approach to assist patient/protocol needs and will extend beyond the completed assignment to assist others.


8. Assesses patient and family educational needs that may include informed consent process, protocol interventions, tests and procedures and disease process.


9. Implements teaching independently and documents results of such teaching to ensure continuity of care through discharge from protocol.


10. Maintains patient rights and confidentiality with attention to safety concerns for the patient.










1. Participates in an orientation program (Cancer Center competencies) and staff development programs relevant to clinical specialty and studies as needed.


2. Participates in all study-related conferences, as assigned.


3. Orients data managers (CRA's) and other study personnel to protocol requirements and work processes


4. Is an active member of Oncology Nursing Society and ARC: Association of Research Coordinators. May be a member of ONS Clinical Trials SIG.


5. Attends formal education outside the medical center (CEU's).


6. Collaborates with other research nurses working on multi site studies across the US via list serves and phone contacts.


7. Shares research education with others who work within the Cancer Institute.


8. Completes the required IRBA/HIPAA tutorial.
















1. Participates in performance improvement initiatives in Cancer Institute, such as work redesign initiatives, Cancer Institute audits of departmental studies, and related work.


2. Utilizes evidence-based practice methods to improve patient care.


3. Participates in and/or coordinates study audits, in conjunction with industry or regulatory representatives.


4. Follow Good Clinical Practice guidelines in accordance with federal regulations (IHC, April 1996).


5. Maintains all study documents in accordance with departmental Standard Operating Procedures and Data Safety and Monitoring Board.

Job Qualifications: 



* Graduate of an accredited School of Nursing


* Licensure as Registered Professional Nurse in NY with current registration


* Bachelor's Degree in Nursing


* Minimum of 3 years relevant nursing experience


* Demonstrate clinical competence in clinical trials nursing practice that includes the ability to execute complex research protocols and to assess and make critical decisions affecting research procedures.