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Organization:

GI Medicine Clinical Trials

Job Summary:

This position will support the GI Clinical Research Enterprise (GICRE) and is responsible for the independent management and oversight of complex clinical research protocols. The Clinical Translational Research Coordinator II will serve as a subject matter expert and lead the coordination of all aspects of clinical trial conduct, including patient recruitment and retention, informed consent, study visits, specimen collection and processing, data management, regulatory compliance, and sponsor interactions. This role collaborates closely with principal investigators, study participants, sponsors, vendors, and multidisciplinary clinical teams to ensure protocol adherence, data integrity, and compliance with institutional, regulatory, and sponsor requirements. The CTRC II exercises a high degree of autonomy in managing study operations, troubleshooting protocol-related issues, and supporting the successful execution of clinical research activities. This position serves as the primary coordinator for the GI Clinical Research Dr Ashley Spann’s PCORI grant. Under the delegation of the Principal Investigator, the Clinical Translational Research Coordinator II is responsible for the receipt, accountability, safe handling, storage, dispensing, reconciliation, and return or destruction of investigational products utilized in clinical trials. The incumbent ensures compliance with sponsor requirements, Good Clinical Practice (GCP), FDA regulations, institutional policies, and study-specific protocols.

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Preferred Skills and Experience:

• Clinical research experience in an academic medical center, hospital, research institute, or healthcare setting
• Experience with patient recruitment, screening, and participant enrollment
• Strong data entry skills with a high degree of accuracy and attention to detail
• Experience interacting directly with patients and providing patient care or patient-facing support
• Electronic Medical Record (EMR/EHR) systems (such as Epic)
• Knowledge of clinical research processes, study protocols, informed consent, and regulatory requirements
• Microsoft Office Suite, especially Excel, Outlook, and Teams
• Ability to manage multiple studies, priorities, and deadlines simultaneously
• Strong written and verbal communication skills for participant, sponsor, and investigator interactions
• Experience resolving data queries and maintaining data quality
• Electronic Data Capture (EDC) systems
• REDCap experience
• Clinical Trial Management Systems (CTMS) experience
  
  

KEY RESPONSIBILITIES

Clinical research project coordination:

• Participate in determination of patient eligibility, engages in the ongoing consent process, coordinates patient visit as per protocol, conducts patient visit, and scheduling of test/procedures. CTRC II will liaison between PI and sponsor to ensure proper execution of clinical trial. Collect and process laboratory samples for shipment to sponsor central lab. 

Investigational product management:

• Specific Examples: The CTRC II is responsible for the daily management of investigational product.  The tasks include, but not limited to, daily storage temperature monitoring, investigational product (IP) receipt, storage, dispensation, IP accountability, labeling, and return of IP  

Documentation / Data Entry:

• Specific Examples: Collect patient data, record patient clinical information into EMR, transcribes data into sponsor database for source documents, resolve data queries in a timely manner.  Ensure that all documentation adheres to ALCOA+C standards and is compliant with GCP regulations. Design source documents for trial data collection.

Regulatory:

• Specific Examples: Prepare and processes new IRB research protocols, amendments, continuing review and adverse event reporting per IRB, sponsor, and federal regulations.  Accurately and compliantly prepares and maintain records for submission to regulatory authorities.  Participates in regulatory authority site visits as well as sponsor’s routine monitoring

Communication:

• Networking with sponsors, vendors, and multiple inter-departments.  Clearly and effectively communicates with PIs, sub-investigators, sponsors, and fellow co-workers. 

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:

Responsibilities:

Certifications :

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.