Nurse, Research Study
Massachusetts General Hospital(MGH)

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.

This is a full-time (40 hours/week) position; evening and weekend hours may occasionally be required to facilitate the conduct of the study

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.

§ 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 (PI) 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.

§ Submits clinical orders in Epic for research-related encounters per study protocol.

§ Conducts follow-up visits with patients as needed, may perform physicals with patients

§ Ensures clinical notes are well documented in EPIC when required

§ Assist with the compilation of relevant patients' medical records from external hospitals/care centers

§ 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 PI in implementing site monitoring plans;

§ Responsible for study-site start-up and teaching

§ Orders equipment/supplies

§ Uses Epic to manage research-related billing including enrolling patients in the study in Epic, linking orders, and reviewing charges per the contract and budget

§ Invoices sponsor for contract-required items using OnCore or appropriate mechanism

Qualifications
SKILLS/ABILITIES/COMPETENCIES REQUIRED:

The Research Nurse should have the following skills and competencies:

§ Ability to forge productive working relationships with patients, families, staff, and co-workers

§ Understanding of clinical research methodology and regulations is essential. Experience in clinical trial coordination, study monitoring and project management required. 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 essential.

§ Cardiology knowledge is preferred

§ Knowledge of hospital systems and competency in MS Office programs, such as Word, Excel, and Outlook

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:

RN from an accredited school of nursing and MA Licensure as an RN.

EDUCATION:

Bachelor of Science in Nursing preferred; new graduates must have a BSN degree.

EXPERIENCE:

Must have 1 - 2 years prior nursing experience; Minimum of 1 - 2 years research-related experience preferred.

SUPERVISORY RESPONSIBILITY:

Orients and trains new staff. Supervises staff in lower-level positions.

FISCAL RESPONSIBILITY:

May monitor and manage study funds. Responsible for preparing invoices, and for directing, verifying, and correcting patient care charges as appropriate in Epic an Insight.

WORKING CONDITIONS:

Duties will be performed in a research office, the operating rooms, and other inpatient and outpatient settings.

EEO Statement
Massachusetts General 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.