CLINICAL RESEARCH NURSE

3 weeks ago

MA United States Massachusetts General Hospital Full time
GENERAL SUMMARY/OVERVIEW STATEMENT:

Under general direction of the Principal Investigator, the Research Study Nurse is responsible for specific aspects of designated research protocols and policies of the clinical studies.

The Tearney Laboratory (www.tearneylab.org) at the Massachusetts General Hospital is a multidisciplinary research laboratory that invents, designs, and validates innovative optical diagnostic imaging devices in human patients. One focus of the laboratory is the development and clinical translation of imaging devices that conduct microscopy of entire organ systems in patients in vivo. A key element of the lab's research involves a clinical study/regulatory team for translation of these medical devices, a critical component of which is a research study nurse.

WORKING CONDITIONS:

Clinical, office, and laboratory setting.

Work may be performed at multiple sites within Massachusetts. Must be flexible in working in multiple locations.

PRINCIPAL DUTIES AND RESPONSIBILITIES

* The research nurse coordinates and implements the research studies according to the study protocol. 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 outpatient setting.
* The research nurse works with physicians, nurses and patients in the selection of and participation by appropriate patients. The research nurse screens all potential and physician-referred patients for protocol eligibility and maintains and submits monthly screening logs.
* The research nurse obtains all necessary approvals and informed consent forms; screens and enrolls patients into the study. The research nurse presents trial concepts and details to the patients, and participates in the informed consent process under the direction of the physician.
* The research nurse documents informed consent process and all components of the study procedures. The research nurse participates in ongoing patient education, coordinates scheduling of tests and treatments required for the protocol maintains research patient database according to Standard Operating Procedures (SOP).
* Using the nursing process, the research nurse delivers professional nursing care, including administration of the device during study procedures. The research nurse performs certain research procedures that include any physical interaction with the research subject by placing the study device or assisting the physician investigator with placing a study device or administering contrast agents during procedures when indicated. The research nurse collects tissue specimens from the research subject during medical procedures (i.e. biopsies) and coordinates the acquisition and documentation of clinical and pathological findings.
* The research nurse evaluates patients' responses to study protocols, provides consultation to primary physicians, nurses and technicians regarding protocol implementation, and contributes to research publications. The research nurse actively participates in protocol initiations and study specific educational programs and communicates and collaborates on an ongoing basis with central operations.
* The research nurse assesses 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. The research nurse assesses patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to device procedure, and thoroughly documents all findings.
* The research nurse works directly with the physician/investigator and clinic staff to ensure protocol compliance and collaborates with the principal investigator on an ongoing basis regarding progress of the study and the continuation or termination of study subjects. Specialized training will be provided for the set-up and operation of the imaging devices as well as monitoring of the performance of the device.
* The research nurse ensures accurate and complete data collection, entry, and timely submission to central operations in accordance with SOPsc coordinates research device procurement and accountability records in accordance with SOPs and participates in and supports all site auditing and monitoring visits.
* The research nurse may be responsible for creating budgets for the research studies. Coordinates payment of non-standard of care protocol-required procedures in order to be compliant with federal and state billing regulations
* The research nurse provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable regulations and laws.
* The research nurse maintains protocol regulatory documents in compliance with SOPs, communicates, reviews, and documents regular Regulatory Meetings with physicians and other clinic staff as appropriate, participates in local quality assurance program and develops appropriate action plans for quality improvement.

EDUCATION:

* BS from an accredited school of nursing required
* MA Licensure as an RN required.

EXPERIENCE:

* Must have prior nursing experience; Two years clinical research experience preferred

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Knowledge of medical terminology, nursing assessment, clinical trials and GCP concepts.
* Ability to read, analyze and interpret technical procedures such as protocols, informed consent documents, and regulatory documents.
* Experience with computer data entry and database management.
* Must have good interpersonal and communication skills.
* Ideal candidates for this position are highly organized with attention to detail and can communicate effectively (written and oral communication).
* Must be 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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