Research Nurse Specialist II, GI Medicine - Onsite Nashville TN

About the role

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 role utilizes clinical nursing expertise to deliver participant care in accordance with study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, and regulatory requirements.

Responsibilities

• Prepare and submit regulatory documents, amendments, continuing reviews, and adverse event reports
• Maintain study documentation
• Coordinate study visits
• Provide research-specific education to participants and study personnel
• Manage investigational products and study supplies
• Support sponsor monitoring visits, audits, and inspections
• Assess participant eligibility
• Monitor for adverse events
• Implement participant retention strategies
• Assist in ensuring high-quality data collection and protocol compliance
• Recruit, consent, screen, enroll, and retain study participants
• Coordinate protocol-required procedures, laboratory collections, investigational product management, and participant follow-up activities
• Distinguish between standard clinical care and research-specific procedures
• Prepare and maintain regulatory documentation, including IRB submissions, protocol amendments, continuing reviews, and adverse event reports
• Ensure compliance with sponsor, institutional, and regulatory requirements throughout the study life cycle
• Perform comprehensive patient assessments and protocol-specific clinical procedures
• Identify, document, and report adverse events and safety concerns in accordance with protocol and regulatory requirements
• Provide patient education and counseling
• Collect, document, verify, and maintain accurate source documentation and research records
• Resolve data queries and support monitoring visits, audits, and inspections
• Build effective working relationships with investigators, sponsors, study participants, regulatory personnel, and interdisciplinary healthcare teams
• Prepare reports, regulatory submissions, and study correspondence

Qualifications

• Bachelor's degree in Nursing (BSN) from an accredited institution; Master's degree preferred
• 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
• Active RN licensure
• Graduate of an approved discipline-specific program
• At least 1 year of relevant work experience

Skills

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 to Biomedical, Applied, and Physical
• Regulatory Compliance (Novice): Demonstrates knowledge of appropriate rules and regulations and applies them in difficult, stressful, and complex situations; able to interpret and explain ambiguous or unclear rules; directs others in interpreting rules and regulations and trains others in them
• Nursing Patient Assessment & Evaluation (Novice): Possesses sufficient fundamental proficiency to assess and evaluate patients in practical applications of moderate difficulty; conducts primary care patient interviews and physical examinations; recognizes problems, asks questions, and contacts the patient's primary care provider and other healthcare team members; gathers pertinent clinical data for 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; competently handles multiple assignments simultaneously by prioritizing work into manageable and measurable units; adapts to changes with minimal disruption; follows up to assure problems and issues are resolved
• Evidence-Based Practice (Novice): Possesses sufficient fundamental proficiency to search for evidence to answer clinical questions; generally works under the direction of others while accomplishing assignments

Core Capabilities

Supporting Colleagues

• Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance 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