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

About the role

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. This position is within the GI Medicine Clinical Trials department.

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 multiple 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

Skills

• 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
• 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.

Qualifications

• Experience: 1 year of relevant work experience
• Education: Bachelor's degree

Benefits

Comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.