Research Staff Nurse
1 month ago
STAFF NURSE- RESEARCH/ CARDIOLOGY/ PER DIEM / DAYS/ BWH BOSTON
GENERAL OVERVIEW:
This position is focused on the conduct of clinical trials in the cardiovascular genetics section, including regulatory and supervisory activities.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Clinical Trials Activities:
* Under the Principal Investigator (PI) co-lead complex phase I-IV interventional clinical trials, in both the inpatient and outpatient setting. In this position there will be direct patient/participant contact.
* Schedule and conduct study visits and train Research Assistant 1 (RA1) and Research Assistant 2 (RA2) to do the same.
* Monitor and report the occurrence of adverse events as dictated by the guidelines of the sponsor and governing IRB. Train RA1 and RA2 to do the same.
* Per protocol telephone or electronic contact with study participants. Train RA1 and RA2 to do the same.
* Review electronic medical records to pre-screen patients for study eligibility. Train RA1 and RA2 to do the same.
* Update PI and Study Coordinator regarding enrollment status and study progress.
* Develop study-specific documents based on study protocol if needed.
* Maintain study documents and ensure study compliance with all government, sponsor, and IRB requirements. Train RA1 and RA2 to do the same.
* Assure adherence to intended timelines and achievement of study goals.
* Maintain clear, concise, accurate and legible records with meticulous attention to detail.
* Maintain confidentiality with regard to patient information and other sensitive information.
* Conform to hospital standards of performance and conduct, including those pertaining to participant rights, so that the best possible customer service and participant care may be provided.
* Administer consent to registry study subjects following Good Clinical Practice (GCP) guidelines.
* Train RAI and RA2 to do all research activities inclusive of, but not limited to, above list.
CLINICAL RESEARCH PRACTICE
A. Organization of Participant Care
* Sets priorities when organizing care for participants
* Maintain continuity through clear and concise (verbal and written) communication.
* Demonstrates appropriate knowledge of Research Good Clinical Practice
B. Quality of Care
* Documents participant care in a manner that is clear, complete, concise and in compliance with research documentation standards.
* Evaluates for adverse and serious adverse events (AE)/(SAE's) and manages the handling of adverse events, compliance and other participant-related issues.
* Provides a safe environment for participants
* Performs nursing procedures safely and efficiently.
* Uses equipment safely and efficiently.
C. Coordination/Collaboration
* Collaborates with other discipline(s) as necessary for every research study.
* Develops, utilizes and research worksheets for workflow of the research study
* Upholds the A.N.A. code of ethics and acts as a role model to other staff members.
* Participates in determining goals and objectives in the periodic review and evaluation.
* Assists the PIs during audits by sponsoring agency or other regulatory bodies if one should occur
* Assists with the recruitment, selection, scheduling, and monitoring of research project participants.
D. Education
* Assumes responsibility for personal and professional growth through identification of own learning needs.
* Shares knowledge and experience with colleagues.
* Participates in unit-based and organizational educational programs.
* Seeks and accepts guidance for additional learning needs.
* Supervises RA1 and RA2, including teaching them the conduct of clinical research
E. Research
* Contributes to nursing and/or medical research endeavors by supporting investigators.
* CITI certification is required
To qualify you must have:
Education:
* Graduate of an approved school of nursing with current registration in Massachusetts.
* Bachelor of Science Degree in Nursing is required.
* Current Massachusetts licensure as a registered professional nurse required.
Experience:
* GCP (Good Clinical Practice) certification required.
* Inpatient cardiology clinical experience required.
* Experience working with outside vendors strongly preferred.
* Experience with program and personnel management strongly preferred.
* Experience with investigational drug studies preferred.
* Ambulatory experience preferred.
* Must be meticulous and detail-oriented concerning the collection and documentation of research data.
* Must possess clinical judgment skills necessary to evaluate, recommend treatment and assesses outcomes for complex patient problems.
* Must be flexible to meet the needs of the Division and the study patients.
* Must possess excellent interpersonal and communication skills.
* Must be self-motivating and work independently.
* Must be proficient in Epic, Microsoft Outlook, Word and Excel.
Other:
* Membership in professional organizations is recommended and certification in a specialty area is encouraged.
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