Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist I is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The Research Nurse Specialist I plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, ensures compliance with protocols and overall research and clinical objectives, manages study-related procedures as required by the protocol, maintains accurate and timely documentation and maintains communication with the sponsor.
Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research and care of participants.
Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse events according to institutional and departmental policies and procedures and federal regulations
Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects
Possesses a basic awareness of the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects (Seeks to attend IRB 101 in-service and completes IRB testing requirements prior to beginning interactions with human subjects)
Communicates a basic knowledge and understanding of the management and implementation of clinical trial operations:
Exhibits the capability to understand and follow a clinical study protocol
Understands and is capable of performing the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
With assistance, prepares and stores critical documents required to be maintained and provided to the sponsor prior to, during and after the conduct of a clinical trial
Identifies and procures equipment and supplies needed to fulfill project requirements
With direction, records data from source documentation onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and source documentation
Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
With supervision, participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Participates in the determination of eligibility and recruits candidates for study participation
With direction assists with study completion, data lock, study closeout and archiving of study files
Ensures completeness and continuity of all study data
Performs ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) to ensure that it is being entered in a timely and accurate manner
Reviews all study data queries correcting any inaccurate data and flagging questionable data for resolution
Collaboratively participates in study team meetings
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research
With guidance assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
Continuously assesses participants to ensure continued eligibility for participation in research
Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical trial
Utilizes nursing skills to complete research protocols including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication dispensing and other protocol specific investigational procedures
Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
With supervision uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
Considers scheduling subject appointments to utilize their and personnel time efficiently
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to nurses conducting clinical research, for example
Demonstrates initiative in self-directed learning, as evidenced by attendance of professional development opportunities. Actively seeks new learning opportunities. Sees learning as part of work.
Assumes responsibility for continuous learning, engaging in a minimum of 5 hours of educational activities annually or pursuing an advanced academic education or certifications
Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
Further knowledge base by attending the Basic Research 101 within first three months of employment date.
Other duties as assigned by PI and/or Administration.
Job requires Graduate of an approved discipline specific program or the equivalent.
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