Clinical Research Nurse
20 hours ago
Mass General Brigham is seeking a highly skilled Clinical Research Nurse to join our team in Boston, Massachusetts.
Job Summary:Under the general direction of the Principal Investigator, physician investigators, and the Clinical Research Program Manager, the Clinical Research Nurse is responsible 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.
Key Responsibilities:- Identify and recruit eligible patients, collect, compile, and complete case report forms for the study sponsor, and coordinate related patient care activities in the inpatient and outpatient setting.
- Work with physicians, NP/PAs, nurses, and patients to screen for study participation.
- Obtain all necessary approvals and informed consent forms, screen and enroll patients into the study.
- Coordinate and implement the research study according to the study protocol, including blood sample collection/phlebotomy and processing.
- Deliver professional nursing care and evaluate patients' responses to study protocols, provide consultation to primary physicians, nurses, and technicians regarding protocol implementation, and contribute to research publications.
- Collaborate with the Principal Investigator (PI) regarding progress of the study, and the continuation/termination of study subjects according to study protocol.
- Act as liaison between patient and other members of the team regarding patient care activities relating to the research protocol.
- Submit clinical orders in Epic for research-related encounters per study protocol.
- Conduct follow-up visits with patients as needed, may perform physicals with patients.
- Ensure clinical notes are well documented in EPIC when required.
- Assist with the compilation of relevant patients' medical records from external hospitals/care centers.
- Manage study documentation, schedule, and prepare for monitoring visits, close out study appropriately.
- Responsible for adverse event monitoring and reporting, document reportable events and other major concerns related to the studies, and disseminate the information to the PI, Study Monitor, and IRB as appropriate.
- Act as liaison with study sponsor, study monitor, and Partners legal, budget, research management teams, and any other department involved in the study.
- Prepare and submit protocols and protocol-related regulatory documents to the Institutional Review Board (IRB); work with the IRB on an ongoing basis throughout the study.
- Assist the PI in implementing site monitoring plans.
- Responsible for study-site start-up and teaching.
- Order equipment/supplies.
- Use Epic to manage research-related billing, including enrolling patients in the study in Epic, linking orders, and reviewing charges per the contract and budget.
- Invoice sponsor for contract-required items using OnCore or appropriate mechanism.
- 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 the 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.
- 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 1 – 2 years prior nursing experience; Minimum of 1 - 2 years research-related experience preferred.
Mass General Brigham is a leading healthcare system in Boston, Massachusetts, dedicated to providing high-quality, safe, and accessible care to patients and communities. We are committed to recognizing and rewarding the unique value each team member brings to our organization.
We offer a comprehensive benefits package, including medical benefits, dental benefits, vision benefits, life insurance, and employee assistance programs.
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