Description
Seeking an experienced RN for the Faustman Immunology Lab located at Massachusetts General Hospital (MGH) Charlestown. The lab conducts innovative Phase II clinical trial focused on the treatment of Type 1 Diabetes. We are testing the potential of BCG, our study drug, to reverse Type I Diabetes in both adults and children (8 years and greater). Please visit www.faustmanlab.org to familiarize yourself with our work.
We are seeking a highly motivated candidate with an interest in clinical research. Benefits eligible part-time 32-hours with a potential for full-time. 100% onsite and predominately early morning visits starting at 7:00AM, M-F.
The Clinical Research Nurse (CRN) in collaboration with the physician, is responsible for the implementation and evaluation of clinical research. The CRN has to have expert skills in:
-conduct and documentation of FDA oversight clinical trials – attention to details and documentation practices
-extremely good IV skills including children 8 years and older – applied daily, 3 children/day
-excellent attendance record since children and families fly in from all over the US and must be met with nurse and meet FDA visit guidelines for timing of visits.
Additional skills required include some knowledge of Type I Diabetes. Strong interpersonal, organizational, collaborative, and excellent communication skills across all age ranges are required. Commitment to continued learning and excellent interactions with team of about 8 members – physicians, clinical research assistants, research assistants, etc. Experience in pediatrics preferred.
Responsibilities:
- Coordinates study enrollment, protocol treatment, and completion of study requirements for patients participating in clinical trials.
- Works collaboratively and functions as an effective member of the research care team.
- Punctual and reliable the RN works with other members to ensure full coverage of patients and flights into Boston.
- Prior mastery of IV insertion daily in 8 -20 year old children; excellent blood drawing skills
- Continued learning of good practices in human clinical trials and daily audit and documentation requirements.
- Provides protocol education to patients and families; adapts interactions based on age-specific needs of the patient.
- Supports research activity within the Faustman Immunology Lab.
- Conducts human research protocols in a carefully monitored controlled, yet dynamic environment to achieve quality outcomes for date research participant safety to support the lab research goals.
- Works collaboratively with study coordinators in maintaining study regulatory binders.
- Collects and prepares required specimens for analysis and monitors test results, as appropriate.
- Documents in StudyTrax as appropriate and communicates observations and findings to protocol investigator.
- Participates in weekly research team meeting and ongoing collaboration with the study team to serve a s a resource person for study coordinators.
- Monitors the environment of care with attention to patient safety and assures compliance with regulatory agency standards.
- Responsible for accurate and complete record keeping for both research and nursing-related data for all study protocols.
- Participates in internal audits in collaboration with study coordinators in all active protocols.
- Assessment of the injection response with documentation (electronic and paper).
- Performs site injections assessment both in person and with Zoom.
- Provides Clinical Lab Test results to subjects.
- Performs Mixed Meal Tolerance Testing (MMTT) on the pediatric population and assists the MD in performing Glucagon Stimulation Testing on the Adult Subjects.
Requirements
Qualifications
- BSN preferred
- Minimum three years of RN experience with both Adult and Pediatric (8 years and older) IV and blood draws required. 5 years of years of RN experience preferred.
- Registered Nurse with current licensure
- Maintains BLS certification
- Clinical Research and Diabetes experience preferred
