The coordinator is responsible for managing the approval processes and execution of research protocols to maintain research integrity and compliance with all policies. Key duties include preparing IRB submissions, maintaining regulatory documents, participating in site visits, recording data accurately, and managing study specimens and budgets.
Requirements summary
Candidates need a Bachelor's degree or equivalent experience (4 years of relevant work experience) to coordinate clinical translational research activities under guidance. The role requires fundamental awareness in project coordination, study design/conduct, communication, and clinical research practices.
Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Organization
Otolaryngology
Job
Summary: In your pivotal role as Clinical Translational Research Coordinator, with some guidance, you will be responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies. This will involve position working with an interdisciplinary research group in the Department of Otolaryngology and Cochlear Implant Cognition and Communication
Laboratory on
NIH-funded studies related to two broad areas:
Development of machine-learning based software to improve examination of the ear
Conducting studies in adult cochlear implant recipients related to speech recognition and patient-reported outcomes. You will be responsible for the coordination and conduct of research protocols in clinical populations, and you will interact in a team fashion with patients, physicians, audiologists, students, and researchers. If you are interested in building clinical research skills, human subjects research, hearing, hearing devices, medicine and surgery, and audiology, this exciting opportunity is for you! You will need a Bachelor's degree or 4 years of equivalent, relevant work experience. You will work Monday-Friday, standard daytime business hours at our office located in the south tower of Vanderbilt Medical Center East at 1215 21st Ave. in Nashville, TN. .
Department
SUMMARY: At the Vanderbilt Department of Otolaryngology–Head and Neck Surgery, we are committed to providing and innovating treatments for the most complex diseases of the head and neck! Our providers are nationally recognized leaders in their field, and our teaching methodology seeks to avoid traditional lectures, putting emphasis, instead, on the flipped classroom. We are proud of our large cohort of residents (26) and our six fellowship training programs (9 fellows). Our decade-old Residency Leadership Training program has been noted in several high-impact journals. Our culture for training is one of "family," with easy accessibility to our stellar faculty and excellent camaraderie among us all. For more information, please visit KEY RESPONSIBILITIES With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures Procures equipment and supplies needed to fulfill project requirements Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation. Engages in open and positive communication with study participants and coworkers With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required The responsibilities listed are a general overview of the position and additional duties may be assigned.
Awareness): Has light experience, training, direct exposure, or past experience with Project Coordination. Has worked on at least one project in a support role. Collects and collates project related material such as project initiation documents, project status reports, project metrics, and project completion data.
Study
Design &
Conduct (Fundamental
Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Communication (Fundamental
Awareness): Clearly, effectively and respectfully communicates to employees or customers.
Clinical
Research (Fundamental
Awareness): Knows the primary resources available to accomplish the job. Can successfully research simple clinical questions pertaining to the functional area. Files and collates trial documentation and reports. Archives study documentation and correspondence. Demonstrates a systematic approach to problem solving 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: Delivers job responsibilities that impact own job area/team with some guidance.
Problem
Solving/
Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement.
Breadth of
Knowledge: Requires subject matter knowledge within a professional area to meet job requirements.
Team
Interaction: Individually contributes to project/ work teams.
Core
Capabilities :
Supporting
Colleagues: -
Develops
Self and
Others: Continuously improves own skills by identifying development opportunities.-
Builds and
Maintains
Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas. -
Communicates
Effectively: Openly shares information with others and communicates in a clear and courteous manner.
Delivering
Excellent
Services: -
Serves
Others with
Compassion: Invests time to understand the problems, needs of others and how to provide excellent service. -
Solves
Complex
Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner. -
Offers
Meaningful
Advice and
Support: Listens carefully to understand the issues and provides accurate information and support.
Ensuring
High
Quality: -
Performs
Excellent
Work: Checks work quality before delivery and asks relevant questions to meet quality standards.-
Ensures
Continuous
Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond. -
Fulfills
Safety and
Regulatory
Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.
Managing
Resources
Effectively :-
Demonstrates
Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service. -
Stewards
Organizational
Resources: Displays understanding of how personal actions will impact departmental resources. -
Makes
Data
Driven
Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.
Fostering
Innovation: -
Generates
New
Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.-
Applies
Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action. -
Adapts to
Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work. Position Qualifications:
Responsibilities
Certifications : Work Experience : Relevant Work Experience Experience Level : Less than 1 year Education : Bachelor's 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. PEOPLE ARE AT THE HEART OF ALL WE DO. Our vision: The world leader in advancing personalized health. Our mission: personalizing the patient experience through our caring spirit and distinctive capabilities. Making Health Care Personal. We’re looking for like-minded individuals driven to make a difference. We invite you to explore careers at Vanderbilt University Medical Center. At VUMC, we place a priority on designing with and for our patients and families. We value collaboration, embrace continuous learning and discovery, and seek to be a place where everyone has the chance to thrive. We’re the largest private employer in Middle Tennessee, with a growing team and expanding footprint in towns and communities across the region. We employ more than 28,000 people who work in inpatient and outpatient clinical care, research, and graduate medical education as well as critical supporting roles in administration, information technology and informatics, finance, legal and community affairs, communications and marketing, fund-raising, groundskeeping and facilities, and many more. Our growing health system has more than 1,700 licensed hospital beds at: Vanderbilt University Hospital Monroe Carell Jr. Children’s Hospital at Vanderbilt Vanderbilt Psychiatric Hospital Vanderbilt Stallworth Rehabilitation Hospital Vanderbilt Wilson County Hospital Vanderbilt Bedford Hospital Vanderbilt Tullahoma-Harton Hospital It’s also home to hundreds of outpatient clinic and surgical locations throughout the region. We serve our community with many unique and specialized services including the Level 1 Trauma Center, a highly experienced Transplant Center that does the most heart transplants in the world, a National Cancer Institute-designated Comprehensive Cancer Center, Lung Institute, Burn Center and many more. World-leading academic departments and centers make scientific discoveries, advance clinical care and train the next generation of health care professionals. Our robust research enterprise consistently ranks among the highest in the country as measured by peer-reviewed grant funding from the National Institutes of Health. We’re honored to be consistently considered among the nation’s best hospitals, including being nationally ranked in multiple medical specialties for treating the most complex conditions in adults and children by US News and World Report. Monroe Carell Jr. Children’s Hospital at Vanderbilt ranked as the No. 1 children’s hospital in the southeast in 2024. We support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at VUMC for professional growth, appreciation of benefits, and a sense of community and purpose. Join us in Making Health Care Personal.
More openings at Vanderbilt University Medical Center
