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Beth Israel Lahey Health · 2 days ago

Clinical Research Specialist RN

Burlington, MA

Full-time

Onsite

Mid, Senior Level

$37/hr - $95.37/hr

4+ years exp

Beth Israel Lahey Health is a growing healthcare organization dedicated to making a difference in people’s lives. The Clinical Research Specialist RN provides direct care to research study participants, implements study protocols, and mentors research staff while ensuring compliance with regulatory requirements.

Elder CareHealth CareHospitalPrimary and Urgent CareProfessional ServicesTraining

Responsibilities

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)

Has direct knowledge and experience in the implementation of all aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations

Functions as a mentor, resource and educator for clinical research coordinators and other colleagues related to Research conducted within the department

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

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

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

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

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

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

Makes suggestions for improvement

Maintains required continuing education credits and nursing license, as applicable

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

Is a team player within the department

Is flexible with time when applicable

Qualification

Clinical trials researchGCP complianceFDA regulationsRegistered Nurse licensureBasic life supportEpic experienceMulti-taskingMedical terminology knowledgeCommunication skillsAttention to detailOrganizational skills

Required

Bachelor's degree in nursing required

Valid Registered Nurse licensure within the state of Massachusetts required

Basic life support required

4+ years direct work related experience in a research or medical setting

Proven ability to take initiative, comprehend regulations, work independently and exhibit leadership

Ability to make decisions that are guided by general instructions and practices requiring some interpretation

Ability to address problems that are varied, requiring analysis of interpretation of the situation using direct observation, knowledge and skills based on education and general precedents

Ability to act as a team leader creating a collaborative and respectful team environment and improving workflows

Ability to travel for clinic activities

Strong verbal and written communication, multi-tasking, attention to detail and organizational skills

Proven ability to function independently, take initiative and to interact with professional personnel at all levels of an organization

Ability to communicate clearly and effectively

Ability to interact with study participants with various diseases compassionately and respectfully

Experience with computer systems, including web based applications

Working knowledge of medical terminology, FDA, OHRP and GCP regulations and medical practice protocols

In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards