Clinical Research Specialist Registered Nurse

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

Under general supervision and direction provides direct care to research study participants and makes necessary nursing judgments. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of specific protocols. Implements study protocols in accordance with regulatory, departmental and institutional requirements.  Uses the nursing process to deliver professional care and evaluation of study participant responses to study protocols. Interacts with study participants diagnosed with various medical conditions and diagnoses. Works closely with investigators and the study team, providing mentoring, direction and guidance to research staff (e.g., Clinical Research Coordinators). 

Will be required to administer chemotherapy and non-chemotherapy infusions as well as injections and blood draws. Training will be provided if necessary.

Will be required to provide direct care to research patients at Lahey Medical Center, Peabody.

Job Description:

Essential Duties & Responsibilities including but not limited to:  

1) Has direct knowledge and experience in the implementation of all aspects of clinical trials research adhering to  

    Research SOPs, GCP compliance and FDA regulations.   

2) Functions as a mentor, resource and educator for clinical research coordinators and other colleagues related to    

    Research conducted within the department.   

3) Functions as an interdepartmental liaison, evaluating, coordinating, and facilitating diverse clinical research projects   conducted by investigators and the study team: 

• Implements, conducts and coordinates assigned research studies by reviewing all pertinent study documents and assessing departmental and institutional requirements. 

• Reviews all pertinent study documents for potential implementation issues and addresses them accordingly. 

• Establishes study processes and procedures, communicates with study team and collaborating departments regarding study requirements; conducts in-services. 

• Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. 

• Advises physicians on required tests, timing of tests, procedures to be followed with suspicious test results, etc. 

• Assures that all appropriate treating physicians receive the results of study tests, as appropriate. 

• Communicates with and develops interdisciplinary relationships with all departments contributing to the successful implementation of the study protocol. 

• Develops tools to assist all departments per study procedures. 

• Develops tools to help laboratory and pharmacy perform all study procedures. 

• Complies with IRB decisions, conditions and requirements. 

• Continuously monitors study activities evaluating practices and procedures; revises as necessary; Updates study processes/procedures according to amendments.  

• Exercises all other responsibilities of clinical research coordination. 

4) Recruits patients to assigned research studies: 

• Identifies eligible patients (e.g., reviews pathology reports in disease specific categories, reviews consultation reports, etc.). 

• Interacts with patients prior to entering the study and throughout the entire treatment; Discusses and obtains informed consent with study participants. 

• Evaluates patient data to deter