Research Nurse Specialist II, GI Medicine - Onsite Nashville TN

United States·Nashvillemid

HealthcareNurse

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Quick Summary

Key Responsibilities

Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.

Technical Tools

HealthcareNurse

GI Medicine Clinical Trials

The Research Nurse Specialist II will provide clinical and operational support for all GICRE studies within the Gastroenterology, Hepatology, and Nutrition division at the Vanderbilt University Medical Center site. The Research Nurse Specialist II will utilize clinical nursing expertise to deliver participant care in accordance with study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, and regulatory requirements.

Additional duties include preparing and submitting regulatory documents, amendments, continuing reviews, and adverse event reports; maintaining study documentation; coordinating study visits; providing research-specific education to participants and study personnel; managing investigational products and study supplies; and supporting sponsor monitoring visits, audits, and inspections. This position will also assess participant eligibility, monitor for adverse events, implement participant retention strategies, and assist in ensuring high-quality data collection and protocol compliance.

Requirements

~1 min read

Bachelor's degree in Nursing (BSN) from an accredited institution; Master's degree.
Minimum of 2 years of clinical nursing experience, preferably in gastroenterology, internal medicine, oncology, or clinical research.
Prior experience coordinating clinical research studies involving human subjects.
Current certification in Good Clinical Practice (GCP) and Human Subjects Protection training, or ability to obtain 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; ACLS certification preferred depending on protocol requirements.
Demonstrated ability to work independently while managing multiple studies and competing priorities.
Strong written and verbal communication skills with the ability to effectively interact with research participants, investigators, sponsors, and regulatory personnel.

Responsibilities:

Certifications:

LIC-Registered Nurse - Licensure-Others

Work Experience:

Relevant Work Experience

Experience Level:

1 year

Education:

Graduate of an approved discipline specific program

This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.

Knowledge of clinical trial processes, research methodologies, and protocol implementation.
Ability to recruit, consent, screen, enroll, and retain study participants.
Experience coordinating protocol-required procedures, laboratory collections, investigational product management, and participant follow-up activities.
Ability to distinguish between standard clinical care and research-specific procedures.

Working knowledge of FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies governing clinical research.
Ability to prepare and maintain regulatory documentation, including IRB submissions, protocol amendments, continuing reviews, and adverse event reports.
Ensures compliance with sponsor, institutional, and regulatory requirements throughout the life cycle of a study.

Ability to perform comprehensive patient assessments and protocol-specific clinical procedures.
Knowledge of disease processes and appropriate clinical interventions.
Ability to identify, document, and report adverse events and safety concerns in accordance with protocol and regulatory requirements.
Strong patient education and counseling skills.

Ability to collect, document, verify, and maintain accurate source documentation and research records.
Knowledge of data integrity principles and quality assurance processes.
Experience resolving data queries and supporting monitoring visits, audits, and inspections.

Ability to build effective working relationships with investigators, sponsors, study participants, regulatory personnel, and interdisciplinary healthcare teams.
Strong presentation and training skills for educating study personnel and research participants.
Excellent written communication skills for preparing reports, regulatory submissions, and study correspondence.

Responsibilities

~2 min read

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.