Research Staff Nurse

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:

1. 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.
2. Schedule and conduct study visits and train Research Assistant 1 (RA1) and Research Assistant 2 (RA2) to do the same.
3. 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.
4. Per protocol telephone or electronic contact with study participants. Train RA1 and RA2 to do the same.
5. Review electronic medical records to pre-screen patients for study eligibility. Train RA1 and RA2 to do the same.
6. Update PI and Study Coordinator regarding enrollment status and study progress.
7. Develop study-specific documents based on study protocol if needed.
8. Maintain study documents and ensure study compliance with all government, sponsor, and IRB requirements. Train RA1 and RA2 to do the same.
9. Assure adherence to intended timelines and achievement of study goals.
10. Maintain clear, concise, accurate and legible records with meticulous attention to detail.
11. Maintain confidentiality with regard to patient information and other sensitive information.
12. 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.
13. Administer consent to registry study subjects following Good Clinical Practice (GCP) guidelines.
14. 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

1. Sets priorities when organizing care for participants
2. Maintain continuity through clear and concise (verbal and written) communication.
3. Demonstrates appropriate knowledge of Research Good Clinical Practice

B. Quality of Care

1. Documents participant care in a manner that is clear, complete, concise and in compliance with research documentation standards.
2. Evaluates for adverse and serious adverse events (AE)/(SAE's) and manages the handling of adverse events, compliance and other participant-related issues.
3. Provides a safe environment for participants
4. Performs nursing procedures safely and efficiently.
5. Uses equipment safely and efficiently.

C. Coordination/Collaboration

1. Collaborates with other discipline(s) as necessary for every research study.
2. Develops, utilizes and research worksheets for workflow of the research study
3. Upholds the A.N.A. code of ethics and acts as a role model to other staff members.
4. Participates in determining goals and objectives in the periodic review and evaluation.
5. Assists the PIs during audits by sponsoring agency or other regulatory bodies if one should occur
6. Assists with the recruitment, selection, scheduling, and monitoring of research project participants.

D. Education

1. Assumes responsibility for personal and professional growth through identification of own learning needs.
2. Shares knowledge and experience with colleagues.
3. Participates in unit-based and organizational educational programs.
4. Seeks and accepts guidance for additional learning needs.
5. Supervises RA1 and RA2, including teaching them the conduct of clinical research

E. Research

1. Contributes to nursing and/or medical research endeavors by supporting investigators.
2. CITI certification is required

To qualify you must have:

Education:

1. Graduate of an approved school of nursing with current registration in Massachusetts.
2. Bachelor of Science Degree in Nursing is required.
3. Current Massachusetts licensure as a registered professional nurse required.

Experience:

1. GCP (Good Clinical Practice) certification required.
2. Inpatient cardiology clinical experience required.
3. Experience working with outside vendors strongly preferred.
4. Experience with program and personnel management strongly preferred.
5. Experience with investigational drug studies preferred.
6. Ambulatory experience preferred.
7. Must be meticulous and detail-oriented concerning the collection and documentation of research data.
8. Must possess clinical judgment skills necessary to evaluate, recommend treatment and assesses outcomes for complex patient problems.
9. Must be flexible to meet the needs of the Division and the study patients.
10. Must possess excellent interpersonal and communication skills.
11. Must be self-motivating and work independently.
12. Must be proficient in Epic, Microsoft Outlook, Word and Excel.

Other:

1. Membership in professional organizations is recommended and certification in a specialty area is encouraged.

Brigham and Women's Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.