Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse 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 recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading 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:

Cardiovascular Med Admin 10

Job Summary:

With guidance and training, this position will act as the senior level research coordinator for the Heart Valve Research Team at VUMC. With assistance from the research manager, this role will be expected to provide day-to-day support and guidance for a team of 4-5 research coordinators overseeing investigational device heart valve trials. This individual will serve as a resource for the research coordinator team and assist in processing requests from Sponsors, the IRB, Health IT, Investigators, and research/clinical team, as well as other research related entities. They will act as a back-up for consenting/enrollment, procedural planning/oversight, and follow-up visits as well as assure that the processes, integrity and quality of the research are assessed and organized in conduct with our teams' systems. This candidate will be responsible for maintenance and submission of IRB documents from 10 - 11 Sponsor studies, cross-checking complex participant billing for compliance and accuracy as well as keeping regulatory documents organized, filed, and communicated to the lead coordinator of each trial.

WHO WE ARE LOOKING FOR:
We are looking for a dedicated individual with a passion for learning and contributing to groundbreaking heart valve research alongside a dynamic, fun, and interdisciplinary heart valve research team, including interventional cardiologist, surgeons, echocardiologist, radiologists, and nurses. This role may require a learning curve for most applicants, but someone that is teachable, willing to learn and eager to grow, and has a foundation of medical knowledge/anatomy would be a good fit.
While this position has the potential to work remotely some days of the week, we are looking for someone that will make themselves available in-person when needed to assist with and oversee exciting procedures with our cath lab team and lend a helping hand to coordinators in valve clinic at times.
Lastly, we are looking for someone that would be interested in growing with our team into a managerial role once acclimated and familiar with day-to-day processes.


Department Summary:

The Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC) is committed to understanding, preventing, and treating cardiovascular disease through: groundbreaking research, providing exceptional patient care, and training the next generation of leaders in cardiovascular medicine.

* Groundbreaking research
* Providing exceptional patient care

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KEY RESPONSIBILITIES

• Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, budgets, and D&H accounts.
• Ability to oversee large and consistently evolving databases. This may include data entry, checking/running queries for completeness/accuracy as well as ensuring Federal and VUMC policies are being followed.
• Meticulous and detail oriented with the ability to organize/file documents consistently and in a way that colleagues/study teams can identify. This includes maintaining original source documentation, utilizing systematic processes, and timely filing/data entry with awareness of good documentation practices.
• Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
• Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process.
• Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures.
• Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. Problem solves when needed
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available 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. Participates in data quality assurance reviews
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner
• 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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools

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: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a "go-to" resource for colleagues with less experience; may lead small project teams.

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:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

3 years

Education :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled