GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under the general direction of the Principal Investigator, physician investigators and the Clinical Research Program Manager, the Research Study Nurse is responsible and accountable for assisting in the implementation of Cardiology research protocols. This full-time position works closely with the study team including study physicians, study monitor and Cardiology administration.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Identifies and recruits eligible patients, collects, compiles, and completes case report forms for the study sponsor and coordinates related patient care activities in the inpatient and outpatient setting.
- Works with physicians, NP/PAs, nurses, and patients to screen for study participation.
- Assist with the compilation of relevant patients' medical records from external hospitals/care centers
- Obtains all necessary approvals and informed consent forms; screens and enrolls patients into the study.
- Coordinates and implements the research study according to the study protocol, including blood sample collection/phlebotomy and processing.
- Using the nursing process delivers professional nursing care and evaluates patients' responses to study protocols, provides consultation to primary physicians, nurses, and technicians regarding protocol implementation and contributes to research publications.
- Collaborates with the principal investigator regarding progress of the study, and the continuation/ termination of study subjects according to study protocol.
- Acts as liaison between patient and other members of the team regarding patient care activities relating to the research protocol.
- Manages study documentation, schedule and prepare for monitoring visits, close out study appropriately.
- Responsible for adverse event monitoring and reporting; documents reportable events and other major concerns related to the studies and disseminates the information to the PI, Study Monitor and IRB as appropriate.
- Acts as liaison with study sponsor, study monitor and Partners legal, budget, research management teams and any other department involved in the study.
- Prepares and submits protocols and protocol related regulatory documents to the Institutional Review Board (IRB); works with the IRB on an ongoing basis throughout the study.
- Assists the P.I. in implementing site monitoring plans.
- Responsible for study-site start-up and teaching.
- Orders equipment/supplies.
The Research Nurse should have the following skills and competencies:
- Cardiology knowledge is preferred
- Understanding of clinical research methodology and regulations is essential.
- Experience in clinical trial coordination, study monitoring and project management is preferred.
- Ability to forge productive working relationships with patients, families, staff, and co-workers.
- Leadership skills, good presentation and writing skills as well as, ability to lead, interact well with others, take initiative and think independently.
- Excellent communication and organization skills required, with attention to detail.
- Knowledge of hospital systems and competency in MS Office programs such as Word, Excel and Outlook.
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable):
RN from an accredited school of nursing and MA Licensure as an RN.
Bachelor of Science in Nursing preferred; new graduates must have a BSN degree.
Must have prior nursing experience; Minimum of 1 - 2 years research related experience preferred.
SUPERVISORY RESPONSIBILITY (if applicable):
Orients and trains new staff. May oversee staff in lower level positions.
FISCAL RESPONSIBILITY (if applicable):
May monitor and manage study funds. Responsible for preparing invoices, and for directing, verifying and correcting patient care charges as appropriate.
Duties will be performed in a research office, the Cardiac Electrophysiology laboratory, and other inpatient and outpatient settings.EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.