Research Nurse Specialist II, GI Medicine - Onsite Nashville TN

Vanderbilt University Medical Center•Nashville, TN

1d•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 deliver participant care in accordance with study protocols, Good Clinical Practice guidelines, institutional policies, and regulatory requirements. The position supports studies throughout their life cycle, including participant eligibility assessment, recruitment and retention, study-visit coordination, protocol-specific clinical care, education, and high-quality data collection. It also involves preparing and submitting regulatory documents, maintaining study records, managing investigational products and supplies, monitoring and reporting adverse events, and supporting sponsor monitoring visits, audits, and inspections.

Requirements

Graduate of an approved discipline-specific program.
Current Registered Nurse licensure.
Minimum of 2 years of clinical nursing experience is stated in the skills and experience description; the position qualifications separately list an experience level of 1 year.
Knowledge of federal regulations governing human-subjects research, including FDA, OHRP, HIPAA, and IRB requirements.
Working knowledge of FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional clinical research policies.
Current GCP certification and Human Subjects Protection training, or ability to obtain them upon hire.
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 participants, investigators, sponsors, regulatory personnel, and interdisciplinary teams.
Ability to perform comprehensive patient assessments and protocol-specific clinical procedures, identify and report safety concerns, and provide patient education and counseling.
Ability to collect, document, verify, and maintain accurate source documentation and research records.
Experience resolving data queries and supporting monitoring visits, audits, and inspections.

Nice To Haves

Bachelor of Science in Nursing (BSN) from an accredited institution.
Master's degree.
Clinical nursing experience in gastroenterology, internal medicine, oncology, or clinical research.
Prior experience coordinating human-subject clinical research studies.
Experience with electronic medical records and clinical trial management systems.
ACLS certification, depending on protocol requirements.
Experience coordinating investigational product management and participant follow-up activities.

Responsibilities

Provide clinical and operational support for GICRE studies within the Gastroenterology, Hepatology, and Nutrition division.
Deliver participant care in accordance with study protocols, GCP guidelines, institutional policies, and regulatory requirements.
Assess participant eligibility and recruit, consent, screen, enroll, and retain study participants.
Coordinate study visits, protocol-required procedures, laboratory collections, and participant follow-up.
Prepare and submit regulatory documents, including IRB submissions, protocol amendments, continuing reviews, and adverse event reports.
Maintain study documentation, source records, and research records, and support accurate data collection and data integrity.
Provide research-specific education to participants and study personnel.
Manage investigational products and study supplies.
Monitor, document, and report adverse events and safety concerns in accordance with protocols and applicable requirements.
Distinguish standard clinical care from research-specific procedures and implement participant retention strategies.
Resolve data queries and support sponsor monitoring visits, audits, and inspections.
Ensure compliance with sponsor, institutional, and regulatory requirements throughout the study life cycle.