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

United States·Nashvillemid

Research AssociateLaboratory & Life Sciences

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Quick Summary

Key Responsibilities

Preparing, submitting, and managing regulatory documents, including IRB adverse event reports, and study-related correspondence. Maintaining essential regulatory, sponsor,

Requirements Summary

Preparing, submitting, and managing regulatory documents, including IRB adverse event reports, and study-related correspondence. Maintaining essential regulatory, sponsor,

Technical Tools

Research AssociateLaboratory & Life Sciences

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.

Responsibilities

~3 min read

→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.

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.

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

Requirements

~1 min read

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.