GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under direct supervision of the CTRU Clinical Research Nurse Manager and Medical Director, the Clinical Research Nurse is responsible for specific aspects of protocols and policies for research studies of neurocognitive disorders and other complex health conditions being conducted in the Clinical & Translational Research Unit at MGH. For purposes of training and oversight for peripheral IV insertion and management, including sampling, the incumbent will similarly receive direction and general supervision from the Director of Nursing for the Translational and Clinical Research Center.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Coordinates and implements the research study according to the study protocol. Acts as a liaison between patient and other members of the team regarding patient care activities relating to the research protocol.
- Collaborates with the PI and other study staff to identify and recruit eligible patients; screens and enrolls patients into the studies. May be required to perform pre-screening assessments in order to determine participant eligibility for study participation.
- Collects, compiles, tabulates and analyzes data for the principal investigator (s)
- Coordinates related patient care activities primarily in the outpatient setting but may on occasion be required to collaborate on in-patient study participants.
- Using the nursing process, delivers professional nursing care and evaluates patients' responses to study protocols.
- Collaborates with the principal investigator (s) on an ongoing basis regarding progress of the study and the continuation or termination of study subjects.
- May be required to assist on submission of protocols/amendments to the IRB for approval. May be required to assist on review of new research protocols to determine nursing needs within the CTRU.
- Obtains all necessary approvals and informed consent forms as approved by the IRB.
- Responsible for all clinical duties as outlined by the research protocol. May include, but is not limited to; IV infusions, including IV insertion, IV management (including drawing blood from an IV line for PK studies), phlebotomy, vital signs, ECGs, cognitive testing, arterial line management, MRI/PET scan and medical emergency response coverage, biofluid sample processing, short/long term storage and shipping.
- Responsible for monitoring study participants for allergic reactions or other adverse events during and post medication administration/infusion including those being cared for in Martino's MRI/PET locations.
- Responsible for manual and electronic data collection, and documentation in accordance with Good Documentation Practices.
- May be responsible for some level of oversight and training of CRC's.
- Participates in daily operational activities necessary for safe patient/staff environment. Knows and adheres to safety precaution techniques for Standard Precautions per Regulatory Standards.
- After training, and with guidance from the Clinical Research Nurse Manager and Clinical Neuropsychologist(s), the successful applicant will;
- Administer standardized neuropsychological tests that assess cognitive and behavioral functioning (including intelligence, attention/executive functions, memory, language, visuospatial/quantitative abilities, mood, and personality) to adult research study participants both with and without cognitive impairment. Administration may be conducted in-person, or virtually via telephone and/or MGB HIPAA compliant Zoom platforms.
- Score assessments according to current scoring guidelines and record scores in the appropriate research database.
- Observe participants during and after testing, record behavioral observations and report to a member of the clinical team, any information that may affect the validity of test results. Record findings in a concise, systematic manner in accordance with clinical research Good Documentation Practices.
- Establish rapport with patients, being sensitive to their psychiatric and/or neurological state over a testing session of up to several hours.
- Assist with maintenance of test equipment and scoring forms.
- Help establish and maintain an appropriate testing environment.
- Performs Quality Control and Preventative Maintenance procedures as required.
- Participates in Quality Assurance/Quality control activities.
SUPERVISORY RESPONSIBILITY (authority to hire, promote, or terminate):
Indirect oversight of Clinical Research Coordinators.
WORKING CONDITIONS:
The successful applicant will be primarily located in the Charlestown Naval Yard but may be required to travel (via MGB Shuttle) to the MGH Main Campus, and other MGH satellite facilities as required.
SKILLS & COMPETENCIES REQUIRED:
Required
- Ability to understands and practice according to ICH Good clinical practices, compliance with all hospital, State and Federal regulatory requirements, including hospital policy and procedures, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).
- Excellent customer service capabilities.
- Ability to work well under pressure.
- Ability to work with staff of diverse educational and ethnic backgrounds.
- Ability to work independently and as a member of a team
- Excellent judgement, attention to detail and organizational skills
- Effective interpersonal and communication skills
- With advanced notice, be able to adapt to flexible scheduling. On occasion, work hours may including working shifts starting between 6am and 8am or ending between 6pm and 8pm as well providing nursing coverage for shifts extending overnight.
Preferred - must be willing to be trained
- IV therapy skills, including the ability to draw blood off a line. Experience with participants of all ages, including pediatric age groups.
- Familiarity with arterial lines.
- Familiarity with MRI/PET environment
- Strong leadership skills.
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Required licensure: Valid Massachusetts RN license required.
Required certifications:
- ACLS (willing to train)
- Good Clinical Practice (willing to train)
- IATA (willing to train)
EDUCATION:
Graduate of an accredited nursing school with current registration in Massachusetts. A Bachelor of Science Degree in Nursing is required for newly licensed nurses.
EXPERIENCE:
Critical care experience and Prior Clinical Trial experience preferred.