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 determine if patient meets further study eligibility and registers or randomizes the study participant to assigned research study. 

5) Provides direct care to research study participants and makes necessary nursing judgments: 

• Demonstrates clinical performance at an expert level utilizing perceptual skills. 

• Coordinates the care of subjects and directs assistive personnel in order to provide safe, effective, efficient patient centered care. 

• Assists physicians with designing and/or implementing study protocol treatment of patients. 

• Acquires detailed knowledge of assigned studies so as to serve as a specialist for the assigned research study and triage calls from the physicians and support staff; Contacts the sponsor for clarification when necessary. 

• Educates study subjects and family on protocol, study interventions, study drug, etc.; acts as a liaison between study subjects and other members of the research team. 

• Assesses subject participation on a continuous basis in light of ethical considerations and protocol compliance. 

• Directly retrieves and/or coordinates the retrieval and submission of patient samples or tests (e.g.,  blood samples, urine samples, tissue, ECG, etc.).  

• Evaluates and monitors the occurrence of adverse events or toxicities in collaboration with the study investigator; Ensures non-serious and serious adverse events are properly documented, and ensures expedited reporting of applicable events (ADEERs). 

• Ensures scientific integrity of study data and protects the rights, safety, and well-being of subjects enrolled in clinical trials. 

6) Completes all necessary paperwork associated with study: 

• Creates and revises source documents as needed and notifies all associated departments of change. 

•   Creates study visit nursing notes and ensures proper and timely placement in the EMR. 

•   Performs data management duties ensuring strong quality of data. 

• Identifies data management issues with PI / sponsor. 

7) Organizes project team meetings and prepares the agenda under direction of the principal investigator. 

8) Accesses, utilizes and follows departmental research SOPs; accesses and adheres to current policies and procedures;  

    Makes suggestions for improvement. 

9) Maintains required continuing education credits and nursing license, as applicable. 

10) Participates and assists in other research projects and initiatives as assigned: 

• Is a team player within the department. 

• Is flexible with time when applicable. 

1 . Director   

receives general direction and oversight; support of research initiatives, regulatory guidance 

2 . Manager / Supervisor 

receives general oversight; support of research initiatives, regulatory guidance 

3 . Sr. Clinical Research Coordinator / Clinical Research Coordinator 

receives support of research initiatives 

4 . Principal Investigators 

receives general oversight; support of research initiatives, regulatory guidance 

5 Research Subjects 

Facilitates access to physicians, and other personnel, services, and assistance with relevant information.