Research Study Nurse

2 weeks ago

Boston MA United States Massachusetts General Hospital Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Under the general direction of the Chief of Division of Transplantation, the Clinical Research Nurse is responsible for assisting the multi-disciplinary Transplant Center Investigators with the conduct of clinical trials according to approved protocols. Will provide direct care to patients enrolled in studies. Will utilize nursing and study knowledge to effectively inform patients regarding study requirements and participation. Complete and maintain study documentation.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The research nurse identifies and recruits eligible patients, collects, compiles, tabulates and analyzes data for the principal investigator, and coordinate related patient care activities in the inpatient and outpatient setting. Using the nursing process, he / she 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 and presents study findings to interested groups both inside and outside of the hospital, coordinates and implements the research study according to the study protocol, provide data form development; and perform required nursing procedures, including drug administration and phlebotomy.

The research nurse will also:

* collaborate with the principal investigators and Transplant Center staff regarding progress of the study and the continuation or termination of study subjects;
* work with physicians, nurses and patients in the selection of and participation by appropriate patients, screening and enrolling patients into the study;
* work with physicians to determine action plans;
* communicate medication changes to subjects and / or families, documenting changes in medical record and with pharmacies;
* obtain all necessary approvals and informed consent forms;
* Works with study sponsors for ongoing study audits and responds to data queries;
* Assess patient participation on a continuous basis in light of ethical considerations;
* Acts as liaison between patient and other members of the team regarding patient care activities relating to the research protocol;
* Assists in budget preparation and IRB submission of protocols.



Depending on the needs of the protocol, the Clinical Research Nurse will be required to:

* perform nursing assessments of subjects to include physical findings and report any adverse events;
* administer research medication as needed;
* evaluate effects of medication for expected and or unexpected results;
* provide documentation of research devices both Category A and B.

QUALIFICATIONS:

* MA Licensure as an RN. Clinical research experience preferred;
* Computer and Internet skills required;
* Familiarity and comfort with Database management, Word, Access and Excel will be necessary to meet job needs



SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Competency in patient care and application of research protocols within the patient care setting;
* Understanding of regulations and requirements related to nursing practice and research protocols;
* The research nurse will have frequent telephone communication with subjects and must be skilled at communicating and obtaining necessary information;
* Will need to know how to assess and report subjects ongoing health and well being in a timely manner;
* Good interpersonal and communication skills;
* Must be able to work independently;
* Is knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).

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