Clinical Translational Research Coordinator II, GI Medicine - Onsite, Nashville TN

Vanderbilt Health; Nashville (TN); Presencial; USD 60.000 - 75.000; Jornada completa

Descripción de la vacante

Vanderbilt Health in Nashville seeks a Clinical Translational Research Coordinator II to manage regulatory documents, screen and enroll participants, and ensure compliance across multiple studies. You will oversee data integrity, sponsor communications, and ethics adherence in a collaborative academic clinical research environment.

As part of the GI Medicine Clinical Trials group, you will coordinate start-up activities, manage study resources, and support audits and regulatory inspections while

Formación

• Experience in coordinating clinical trials and regulatory requirements.
• Familiarity with IRB submissions, GCP and human subject protection.
• Strong data management, QA practices, and documentation discipline.
• Effective cross-functional communication and teamwork.

Responsabilidades

• Preparing, submitting, and managing regulatory documents, including IRB adverse event reports, and study-related correspondence.
• Maintaining essential regulatory, sponsor, and study documentation to ensure audit readiness.
• Coordinating study operations and procuring equipment, supplies, and resources for trials.
• Screening, recruiting, consenting, and enrolling participants per protocol.
• Evaluating medical records to confirm eligibility and ongoing compliance.
• Managing data in paper/electronic case report forms and resolving queries.
• Supporting sponsor monitoring visits, audits, and inspections with source documentation.
• Processing, packaging, and shipping biological specimens per protocol.
• Assisting with payment tracking and trial billing compliance.
• Facilitating informed consent and ensuring participant understanding.
• Advocating for participant safety and ethical conduct.
• Participating in research committees to improve processes.

Conocimientos

Clinical Trial Management

Regulatory Affairs & IRB Submissions

Good Clinical Practice (GCP)

Human Subjects Protection

Participant Recruitment & Retention

Informed Consent Administration

Data Management & Quality Assurance

Sponsor and Regulatory Audits

Budget & Financial Oversight

Specimen Collection & Shipping

Site Management

Cross-Functional Communication

Project Coordination & Problem Solving

Educación

Bachelor's degree

Herramientas

Clinical Research (Novice)

Study Design & Conduct (Novice)

Project Coordination (Novice)

Communication (Novice)

Descripción del empleo

Discover Vanderbilt Health

With eight hospitals and over 180 clinics, we are the region's largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you'll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

Organization: GI Medicine Clinical Trials

Job Summary

The Clinical Translational Research Coordinator II demonstrates comprehensive expertise in the coordination and management of clinical and translational research studies while ensuring compliance with institutional policies, federal regulations, Good Clinical Practice (GCP), and human subject protection requirements.

Key Responsibilities

• Preparing, submitting, and managing regulatory documents, including IRB adverse event reports, and study-related correspondence.
• Maintaining essential regulatory, sponsor, and study documentation to ensure audit and inspection readiness throughout all phases of a clinical trial.
• Coordinating study operations by procuring equipment, supplies, and resources necessary for successful trial execution across multi studies.
• Screening, recruiting, consenting, and enrolling participants while ensuring adherence to protocol-specific inclusion and exclusion criteria.
• Evaluating medical records and participant histories to confirm eligibility and ongoing compliance with study requirements.
• Managing clinical research data by accurately entering information into paper and electronic case report forms, resolving data queries, and ensuring data integrity and regulatory compliance.
• Supporting sponsor monitoring visits, audits, and regulatory inspections through maintenance of source documentation, study records, and research procedures.
• Processing, packaging, and shipping biological specimens in accordance with protocol requirements, laboratory standards, and applicable shipping regulations.
• Assisting with payment tracking and clinical trial billing compliance.
• Facilitating the informed consent process and ensuring participants and their families have a clear understanding of study requirements, risks, and expectations.
• Serving as an advocate for research participants by promoting ethical conduct, participant safety, regulatory compliance, and effective communication among investigators, sponsors, research staff, and participants.
• Actively participating in research-related committees and institutional initiatives to promote continuous process improvement and best practices in clinical research.

Core Competencies

• Clinical Trial Management
• Regulatory Affairs & IRB Submissions
• Good Clinical Practice (GCP)
• Human Subjects Protection
• Participant Recruitment & Retention
• Informed Consent Administration
• Data Management & Quality Assurance
• Sponsor and Regulatory Audits
• Budget & Financial Oversight
• Specimen Collection & Shipping
• Study Start-Up & Site Management
• Cross-Functional Communication
• Research Compliance
• Project Coordination and Problem Solving

TECHNICAL CAPABILITIES

• Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
• Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
• Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.
• Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.

Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

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 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.

Position Qualifications

Work Experience: Relevant Work Experience

Experience Level: 1 year

Education: Bachelor's

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.