Job Abstract

The Clinical Research Nurse II for the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) will work under the direction of the CNRU Director and in collaboration with the CNRU inpatient team to educate staff on various research activities and ensure that the clinical activities for study participants are conducted in accordance with approved protocols.?

Responsibilities include develops and implements procedures and data quality assurance standards for safety monitoring components of studies. Contributes to designing activities, policies, and procedures to improve day to day efficiency of research activities on the CNRU, assessment components of various studies, and to ensure that the CNRU nurses and mental health assistants properly perform activities within established research protocol. Delegates tasks and supervises the activities of other licensed and unlicensed care providers. With limited supervision and oversight from the Director of the CNRU, serves as the clinical research point person for all study protocols, both inpatient & outpatient.

Essential Duties include evaluates and assesses research protocols and develops and modifies procedures according to individual study needs. Recommends changes to the study protocol to coincide with study goals, objectives, and available resources. Perform nursing duties for specific research protocols, in collaboration with CNRU nursing staff, including assessment, vital signs, phlebotomy, EKGs, placement and management of IVs, management of clinical records, and related tasks. Develops and implements procedures, flowsheets, and data quality assurance standards for safety monitoring components of studies as related to nursing care.??

Contributes to designing unit policies and procedures to improve day to day efficiency of the CNRU and to ensure that nursing staff perform assigned activities within established research protocol. Collaborates with multidisciplinary researchers to coordinate research studies on the CNRU that integrate new advances in clinical trials. Delegates tasks and supervises the activities of other licensed and unlicensed care providers.?Educates and trains CNRU nursing staff on nursing-specific responsibilities and tasks related to each individual protocol. Collaborates with CNRU nursing leadership to schedule and maintain all research activities on the CNRU. Collaborates with CNRU Program Manager and Lab Manager to maintain service contracts for lab equipment, including cryofreezer and centrifuges, and train research staff in proper use of CNRU lab equipment. Ability and willingness to educate and train both nursing and research staff in clinical skills and tasks as appropriate.? Knowledge of research protocols an ability to review all proposed protocols for accuracy and feasibility to conduct each protocol on the CNRU. 1. Coordinates, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for moderately to highly complex protocols. 2. Assists study feasibility reviews. 3. Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. 4. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties. 5. Builds, reviews, and approves accurate and complete order sets to ensure compliance with individual research protocols. Reviews Beacon order set with CRC in anticipation of upcoming participant’s clinic visit. Pends orders for routing to Investigator for approval and signature. 6. Assists in ensuring Principal Investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events, and other documents as required. 7. Develops and participates in the delivery of training for new protocols, including the creation of training materials, protocol-specific tool kit, nursing in-service presentations and others as required by specific protocols. Determines the appropriate training delivery mechanism, timing, and frequency. 8. Performs direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements. 9. Maintains the integrity of the clinical research study by striving to advocate for patients and families. Serves as clinical resource for triaging and addressing research related inquiries generated from YCC websites and professional presentations. 10. Provides patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate. 11. Serves as front line medical person in interpreting protocol to medical and nursing staff, particularly concerning dose medications and safety issues related to the administration of the study drug or treatment. 12. Participates in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome. 13. Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations. 14. Performs other duties as assigned. Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined proven experience, or the equivalent combination of education or demonstrated experience. Demonstrated experience must indicate the ability to work with minimal supervision in a team environment.