Research Nurse Specialist II, GI Medicine - Onsite Nashville TN

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Organization

GI Medicine Clinical Trials

Job Summary

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..

Preferred Skills & Experience

• 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.

Clinical Research Operations

• 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.

Regulatory Compliance

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.

Clinical Nursing Skills

• 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.

Data Management and Quality Assurance

• 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.

Communication and Collaboration

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.

Technical Capabilities

• Scientific Knowledge (Novice): Knowledge of different scientific studies including but not limited Biomedical, Applied, and Physical.
• Regulatory Compliance (Novice): Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.
• Nursing Patient Assessment & Evaluation (Novice): Possesses sufficient fundamental proficiency to successfully demonstrate the ability to assess and evaluate patients in practical applications of moderate difficulty. Conducts primary care patient interviews and physical examinations. Demonstrates sufficient acumen to recognize problems, ask questions and to contact the patient's primary care provider and other members of the healthcare team. Has experience in gathering pertinent clinical data that aid in referral, treatment, or other primary care pathways.
• Nursing Patient Education (Novice): Possesses sufficient fundamental proficiency in providing patient education in practical applications of moderate difficulty.
• Care Planning (Novice): Demonstrates ability to anticipate resource needs, identify distinct tasks, set priorities, schedule activities, meet deadlines, and organize work within areas of direct responsibility. Competently handles multiple assignments often simultaneously by prioritizing work into manageable and measurable units. Ability to adapt to changes to patient care and area needs with minimal disruption and loss of productivity. Follows up to assure problems and issues are resolved.
• Evidence-Based Practice (Novice): Possesses sufficient fundamental proficiency to successfully search for evidence to answer clinical questions. Generally works under the direction of others while accomplishing assignments.

Our Nursing Philosophy

We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center’s mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.

As a Vanderbilt University Medical Center employee, you make a difference to our patients and their families by bringing compassion and care to those in need of hope and healing. Please see our current employee benefits offered:

• Affordable High Quality Health Plan Options
• Dental and /or vision plan
• 403 (b) retirement plan
• Paid Time off (flex PTO)
• Tuition Reimbursement and adoption assistance (maximums applied)
• Short-Long term disability

Subsidized Backup Childcare

And many more... Ask us about our current inpatient nursing supplemental Pay Program!

Achieve the Remarkable

Learn more about VUMC Nursing here.

Core Accountabilities

Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

Core Capabilities

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 understandin