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).
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 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.
Organizational Requirements:
- 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.
Minimum Qualifications:
Education:
Bachelor’s degree in nursing required; Master’s degree in nursing preferred
Licensure, Certification & Registration:
Valid Registered Nurse licensure within the state of Massachusetts required
Basic life support required
Experience:
4+ years direct work related experience in a research or medical setting; experience with cooperative group trials preferred; proven ability to take initiative, comprehend regulations, work independently and exhibit leadership; Epic experience a plus.
Skills, Knowledge & Abilities:
Ability to make decisions that are guided by general instructions and practices requiring some interpretation; May make recommendations for solving problems of moderate complexity and importance; 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; Seeks assistance when confronted with difficult and/or unpredictable situations; 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.
Key Relationships:
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.
Pay Range:
$37.00 – $95.37
The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.
