Clin/Tran Research Coord II

Vanderbilt University Medical Center; Nashville (TN); On-site; USD 55,000 - 75,000; Full time

Job summary

Vanderbilt University Medical Center in Nashville seeks a Clinical/Translational Research Coordinator II to join the CIBS Center’s TBI Hub. The role spans screening, enrollment, consent, and long-term follow-up in federally funded studies, with a focus on advancing care for brain injury patients through coordinated multi-site research.

You will manage IRB tasks, data collection, regulatory documentation, and safety reporting while coordinating with investigators, sponsors, and the care team.

Qualifications

• Bachelor’s degree (or equivalent experience).
• 1 year of relevant experience in clinical research.
• Must complete a Research 101 course within six months of hire.

Responsibilities

• Prepare, submit, and manage IRB applications per policies and federal regs.
• Conduct and support procedures: screening, recruitment, scheduling, consent, interviews, assessments, specimen collection, EEG/MRI and other activities.
• Accurately collect, document, and enter study data from source documents into CRFs.
• Maintain regulatory documents to ensure ongoing GCP compliance.
• Monitor participant safety by identifying and reporting adverse events as required.
• Coordinate packaging and shipment of biological specimens with proper documentation.
• Participate in site visits, audits, and sponsor/regulatory authority monitoring.
• Collaborate with investigators, sponsors, and teams, advocating for human subject protections.
• Assist with operations: equipment, budgets, invoicing, and billing compliance.
• Engage in ongoing professional development to advance clinical research expertise.

Skills

Excellent written and verbal comms

Attention to detail

Initiative and judgment in clinical 연구

Adaptability and prioritization

Education

Bachelor’s degree (or equivalent experience)

Job description

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.

Job Summary

In your pivotal role as a Clinical/Translational Research Coordinator II (CTRC II), you will join the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center’s Traumatic Brain Injury (TBI) Hub—a collaborative program managing multiple federally funded, local, and multi-center interventional and observational studies. Our mission is to improve clinical care and long-term outcomes for patients with acute brain injury, including individuals with disorders of consciousness. To advance this mission, our team identifies, screens, enrolls, and follows patients from the acute hospital setting through long-term recovery.

What success looks like in this role

• Excellent written and verbal communication skills
• Strong attention to detail and organizational skills
• Initiative and sound judgment in a clinical research setting
• Adaptability and comfort managing competing priorities
• A mindset of continuous improvement and process optimization

Requirements

• Bachelor’s degree (or equivalent experience)
• 1 year of relevant experience
• Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.

Work location and schedule

On-site at Vanderbilt Medical Center North (21st Ave., Nashville, TN)

Schedule is primarily Monday–Friday, daytime business hours

Flexibility is essential, with occasional weekend work as needed

DEPARTMENT SUMMARY

For over 40 years, our Vanderbilt Acute Care Surgery faculty have provided expertise in disciplines of trauma, burn, emergency general surgery and surgical critical care across VUMC for Middle Tennessee and outlying communities. Essential for the delivery of quality of surgical care are our facilities, which include our Trauma, Burn and Surgical ICUs, and our partnership with LifeFlight, our active ground and air medical transport program. We are the only Level I Adult Trauma center for our region, with state and national certifications by the American College of Surgeons. For more information, please visit https://www.vumc.org/trauma-and-scc/division-acute-care-surgery.

KEY COMPETENCIES

• Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research
• Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
• Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations

Key Responsibilities

• Prepare, submit, and manage IRB applications (new studies, amendments, continuing reviews, and adverse event reports) in compliance with institutional policies and federal regulations.
• Conduct and support study procedures, including participant screening, recruitment, scheduling, informed consent, interviews, assessments, specimen collection, and assisting with EEG/MRI and other protocol-required activities.
• Accurately collect, document, and enter study data from source documents into paper or electronic case report forms, ensuring completeness, accuracy, and timeliness.
• Prepare, maintain, and organize regulatory and essential study documents to ensure ongoing compliance with Good Clinical Practice (GCP).
• Monitor participant safety by identifying, documenting, and reporting adverse events in accordance with protocol, IRB, FDA, sponsor, and institutional requirements.
• Coordinate packaging and shipment of biological specimens in compliance with sponsor, laboratory, and shipping regulations, maintaining required documentation.
• Participate in site visits, audits, and monitoring activities by sponsors and regulatory authorities, addressing queries and resolving findings in a timely manner.
• Collaborate professionally with investigators, participants, sponsors, and multidisciplinary teams, serving as an advocate for human subject protections.
• Assist with study operations, including equipment and supply procurement, budget development and tracking, invoicing, and ensuring clinical trial billing compliance.
• Engage in ongoing professional development through required training, certificates, research councils, and continuous education to maintain and advance clinical research expertise.

Physical Requirements/Strengths Needed & Physical Demands

• Occasional: Sitting: Remaining in seated position, Standing: Remaining on one's feet without moving., Walking: Moving about on foot., Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another, Push/Pull: Exerting force to move objects away from or toward., Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles, Reaching below shoulders: Extending arms in any direction below shoulders., Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

Sensory

• Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
• Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
• Continuous: Communication: Expressing or exchanging written/verbal/electronic information. Environmental Conditions

Vanderbilt University Medical Center is an Equal Opportunity Employer and adheres to the parameters of Section 504 of the Rehabilitation Act of 1973. In compliance with the Americans with Disabilities Act as amended, we will provide reasonable accommodations to qualified individuals with disabilities and encourage both prospective and current employees to discuss potential reasonable accommodations with us.

Our Academic Enterprise

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

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.