CHEManager International · 5 days ago
Clinical Research Specialist RN
Burlington, MA
Full-time
Onsite
Mid Level
$37/hr - $95.37/hr
4+ years expCHEManager International is part of the growing BILH team, 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.
Newspapers
Responsibilities
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
Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy
Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities
Comply with all Lahey Hospital and Medical Center Policies
Comply with behavioral expectations of the department and Lahey Hospital and Medical Center
Maintain courteous and effective interactions with colleagues and patients
Demonstrate an understanding of the job description, performance expectations, and competency assessment
Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards
Participate in departmental and/or interdepartmental quality improvement activities
Participate in and successfully completes Mandatory Education
Perform all other duties as needed or directed to meet the needs of the department
Qualification
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
Demonstrates the ability to be thoroughly trained to meet organizational standards
Preferred
Master's degree in nursing preferred
Experience with cooperative group trials preferred
Epic experience a plus
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase