Research Nurse Specialist II, GI Medicine - Onsite Nashville TN

Vanderbilt University Medical Center•Nashville, TN

2d•Onsite

About The Position

The Research Nurse Specialist II provides clinical and operational support for GICRE studies within the Gastroenterology, Hepatology, and Nutrition division at the Vanderbilt University Medical Center site. The role uses clinical nursing expertise to provide participant care consistent with study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, and regulatory requirements. The specialist prepares and submits regulatory documents, amendments, continuing reviews, and adverse event reports; maintains study documentation; coordinates study visits; educates participants and study personnel on research-specific matters; manages investigational products and study supplies; and supports sponsor monitoring visits, audits, and inspections. The role also assesses participant eligibility, monitors for adverse events, implements participant-retention strategies, and helps ensure high-quality data collection and protocol compliance. The position requires nursing licensure and a graduate of an approved discipline-specific program. The posting lists a minimum of one year of relevant work experience and identifies a BSN, at least two years of clinical nursing experience, clinical research coordination experience, and several research-related certifications and skills as preferred or required qualifications. The position is onsite in Nashville, Tennessee.

Requirements

Registered Nurse licensure is required (LIC-Registered Nurse).
Graduate of an approved discipline-specific program.
At least 1 year of relevant work experience is listed in the position qualifications.
The preferred skills section specifies a minimum of 2 years of clinical nursing experience, preferably in gastroenterology, internal medicine, oncology, or clinical research.
The preferred skills section specifies a bachelor's degree in Nursing (BSN) from an accredited institution; a master's degree is also listed.
Prior experience coordinating clinical research studies involving human subjects.
Current GCP certification and Human Subjects Protection training, or ability to obtain them upon hire.
Knowledge of federal regulations governing human subjects research, including FDA, OHRP, HIPAA, and IRB requirements.
Experience with electronic medical records (EMR) and clinical trial management systems.
BLS certification required.
Ability to work independently while managing multiple studies and competing priorities.
Strong written and verbal communication skills and ability to interact effectively with research participants, investigators, sponsors, and regulatory personnel.
Knowledge of clinical trial processes, research methodologies, protocol implementation, FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional clinical research policies.
Ability to perform patient assessments, provide patient education and counseling, and identify appropriate clinical interventions and safety concerns.
Ability to collect, document, verify, and maintain accurate source documentation and research records.
Knowledge of data integrity principles and quality assurance processes.
Ability to build effective working relationships and prepare reports, regulatory submissions, and study correspondence.

Nice To Haves

Master's degree.
Clinical nursing experience in gastroenterology, internal medicine, oncology, or clinical research.
ACLS certification, depending on protocol requirements.
Experience with electronic medical records and clinical trial management systems.

Responsibilities

Provide clinical and operational support for GICRE studies in the Gastroenterology, Hepatology, and Nutrition division at the Vanderbilt University Medical Center site.
Deliver participant care in accordance with study protocols, GCP guidelines, institutional policies, and regulatory requirements.
Prepare and submit regulatory documents, protocol amendments, continuing reviews, and adverse event reports.
Maintain study documentation and accurate source records.
Coordinate study visits and protocol-required procedures, laboratory collections, and participant follow-up activities.
Provide research-specific education to participants and study personnel.
Manage investigational products and study supplies.
Support sponsor monitoring visits, audits, and inspections; resolve data queries as needed.
Assess participant eligibility and recruit, consent, screen, enroll, and retain study participants.
Monitor for, document, and report adverse events and safety concerns.
Support high-quality data collection, data integrity, and protocol compliance.
Perform comprehensive patient assessments and protocol-specific clinical procedures.
Distinguish standard clinical care from research-specific procedures.
Coordinate with investigators, sponsors, participants, regulatory personnel, and interdisciplinary healthcare teams.
Educate and train study personnel and research participants.
Organize work, prioritize competing assignments, meet deadlines, and adapt to changing patient-care and area needs.