Clin/Tran Research Coord II

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.

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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, certifications, 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 Enterpriseis 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 VanderbiltHealth’s Strategic Directions, the Office of Research provides shared researchresources, administrative expertise and professional guidance toenable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff. 

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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.