Clinical Research Coordinator III - Hematology/Oncology at Vanderbilt University Medical Center

Nashville, Tennessee, United States -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

0.0

Posted On

14 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

People Management, Clinical Research, Study Design & Conduct, Communication, Project Coordination, Data Quality Assurance, Protocol Coordination, Patient Recruitment, Specimen Handling, Budget Management, Regulatory Compliance, Process Improvement, Performance Metrics, Team Building, Delegation, Coaching

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: Hematology/Oncology Research Job Summary: 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, independently. . Department Summary: The Division of Hematology and Oncology at Vanderbilt University Medical Center conducts research and treats all types of adult cancers including solid tumor cancers and hematological (blood) disorders, as benign hematologic disorders such as coagulation disorders and non-cancerous blood diseases. With over 80 faculty members representing a broad range of professional expertise, our dedicated team of professionals is committed to hematologic and oncologic care through: Research to better understand and treat cancers and benign hematologic diseases Translating VICC laboratory research into therapies to help people with cancer State-of-the-art patient care and personalized cancer therapy Clinical trials, including Phase I drug development with subsequent Phase II and Phase III testing Training future hematology and oncology doctors and researchers Cancer chemotherapy, pharmacology, and biological therapy with an emphasis on solid tumors Treating bleeding and coagulation disorders, anemia and other disorders of blood KEY RESPONSIBILITIES • 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. • Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures • Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required) • 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 • Receives and tracks receipt and status of study specimens from multiple sites. 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 • Responsible for study completion processes including data lock, study closeout, reporting 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 and assuring archival of appropriate/required documentation • With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to 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 public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants. With guidance, assesses and evaluates potential participants pertinent medical and historical information. • Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting • Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes • The responsibilities listed are a general overview of the position and additional duties may be assigned. TECHNICAL CAPABILITIES • People Management (Novice): Conducts performance reviews. Effectively delegates tasks to others. Coaches subordinates on technical and interpersonal topics, as well as professional development. Demonstrates team building techniques and provides leadership through personal example of good work habits, open communication and effective people relationships. Involves subordinates in decisions which affect them. Demonstrates self-reliance and resourcefulness as an example to others. • Clinical Research (Intermediate): Demonstrates the ability to effectively research complicated issues pertaining to the area of expertise. Presents trial protocols to a steering committee. Often employs networking to help in researching issues. Sets up study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards. Has used research resources maintained in outside areas. • Study Design & Conduct (Intermediate): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study. • Communication (Intermediate): Clearly, effectively and respectfully communicates to employees or customers. • Project Coordination (Intermediate): Performs project tracking and reporting relative to task completion dates, dependency effects, problem anticipation, schedule conflicts, and assignment to appropriate staff for resolution. Manages prioritization procedures for changing scope [i.e., change management] and project acceptance procedures. Measures progress toward goals and revises project objectives and documents applying change control procedures. Assumes responsibility [as appropriate] for resolving issues and seeing work through to successful completion. Provides training to project managers and others on project related templates and toolsets. Develops methods to measure customer satisfaction and obtains feedback at critical milestones and at project completion to ensure project efforts meet customer expectations. 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 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 coordinator is responsible for independently managing the approval processes and execution of research protocols to maintain research integrity and quality while adhering to all policies. Key duties include preparing and maintaining required documentation, coordinating patient activities like recruitment and scheduling, managing study budgets, and advocating for human subjects' protection.