Clinical Research Coordinator II (Term Position) at Vanderbilt University Medical Center

Nashville, Tennessee, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Study Design, Project Coordination, Communication, Data Management, Regulatory Compliance, Budget Management, Participant Recruitment, Informed Consent, Problem Solving, Team Collaboration, Documentation, Equipment Procurement, Quality Assurance, Human Subject Advocacy, Continuous Improvement

Industry

Hospitals and Health Care

Description

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 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: Cardiovascular Medicine Job Summary: This is a midlevel patient facing coordinator position that will take a lead role in contents of all aortic valve clinical trials. 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 A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. . KEY RESPONSIBILITIES Proficiently 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 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 Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required) Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. 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 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. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures 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, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies 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 ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel The responsibilities listed are a general overview of the position and additional duties may be assigned. TECHNICAL CAPABILITIES Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues. Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study. Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories. Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers. 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: Responsibilities: Certifications: Work Experience: Experience Level: Education: 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.

Responsibilities

The Clinical Research Coordinator II will lead the coordination of aortic valve clinical trials, ensuring compliance with regulatory requirements and maintaining accurate documentation. Responsibilities include participant recruitment, data management, and communication with stakeholders involved in the research process.