Job Description

Under general direction of the Principal Investigator and the Research Nurse Manager, the Clinical Research Nurse is responsible for implementing and coordinating all aspects of the department's research trials and physician-initiated trials as assigned.

The Clinical Research Nurse will oversee the management of the physician initiated clinical research trials. The RN acts as a liaison between the Principal Investigator, other clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other involved research staff to ensure adherence to the protocol. The RN coordinates the implementation of the research protocol through study closeout of clinical research studies ensuring data validation, regulatory compliance, and quality control.

The Clinical Research Nurse is responsible for:

* Providing direct patient care during research follow-up visits in the outpatient clinic.

* Works with administrative staff to schedule patient protocol screening, study procedure, and follow-up.

* Serving as a clinical resource to the research team, including research coordinators.

* Ensuring medication compliance and completing specified assessments and questionnaires in accordance with study/department protocols.

* Maintaining and completing meticulous records/source documentation for all study patient records. This includes documenting applicable notes in EPIC

* Reviewing research subject medical records, abstracting data, completing the case report forms (CRFs), recording the information in the electronic data capture systems (EDC), and responding to applicable data queries.

* Adhering to all study-specific deadlines/data base locks

* Reporting adverse events, serious adverse events, and unanticipated device adverse events in accordance with the protocol and the Partners Human Research Committee policies. Serves as the first consult to research coordinators when reporting adverse events.

* Ensures protocol required imaging (XRAYS, CT, MRA, Ultrasounds) are done in accordance with protocol and are sent to the appropriate core labs in the specified format.

* Completing and documenting the informed consent process in EPIC with the physician and study patient in accordance with Partners Human Research Committee policy along with Good Clinical Practice and ICH guidelines.

* Attending the study procedure in the OR and/or cath lab/Interventional radiology. This includes completing any pre- and post-procedure assessments required per protocol, collecting study related data, as well as the delivery, tracking, and if needed return, of the investigational devices. The RN will also communicate and ensure compliance of the study protocol during the procedure.

* Ensuring timely patient treatment by verifying investigational device orders, device receipt and that devices are securely tracked. Complies with OR products committee requirements for product tracking.

* Provides hospital billing department with appropriate information to ensure product reimbursement. This includes confirming adequate research documentation is entered into EPIC.

* Utilizes clinical expertise to support monitoring/audit visits. This includes scheduling, obtaining electronic medical record (EPIC) access for the study monitor, completing the necessary data corrections, and responding to queries/other issues raised during these visits. S/he will also institute corrective action plans as necessary.

* Manages/assists with FDA audits. This requires knowledge of BioMo Audit guidelines and strict adherence to FDA regulations. The RN responds to all FDA findings in a timely manner.

* Prepares IRB submissions including IDE Safety Letters, Protocol Amendments, Continuing Review Reports, Protocol Violations and Deviations, and Serious Adverse Event Reports as necessary.

* Collecting, preparing, and shipping protocol-related lab samples and devices as applicable

* Maintains GCP, CITI, and stroke scale (NIH and MRS) certifications. Attends annual continuing education training related to clinical research and vascular surgery.

* Attends sponsor held coordinator meetings/trainings as necessary

* May provide nursing coverage in the vascular surgery outpatient clinic as needed.

* Supports and guides other study team members in the implementation of study related activities. Reviews the work of trainees.

May assist in other program responsibilities as needed. On call schedule (dependent on enrolling trials) may be required.

Education: Graduate of an approved school of nursing with current registration in Massachusetts.

Experience: Some clinical research experience required. Nursing experience and certification in clinical research is preferred.

MassachusettsGeneral Hospital is an Equal Opportunity Employer. By embracing diverseskills, perspectives and ideas, we choose to lead. Applicationsfrom protected veterans and individuals with disabilities are stronglyencouraged.
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