Job Title: Clinical Research Associate 2 - VICTR - VCC
This is a full-time/exempt term position lasting six months to one year.
The Clinical Research Associate 2 will be housed in the Vanderbilt Coordinating Center (the central clinical trial office within the Vanderbilt Institute for Clinical and Translational Research). The CRA2 will monitor the progress of clinical studies primarily remotely (although under special circumstances may need to be physically present at investigative sites), and will help ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The CRA2 is critical to ensuring that a study's endpoints can be properly assessed by acting as the first line of defense for all data oversight. The CRA2 ensures data collected at participating centers is accurate, initiates data adjudication processes, solves operational problems, informs best practices for data management, and prepares a wide range of statistical reports. This position is responsible for data management of studies involving pharmaceuticals, biologics, or devices and for supporting and informing the corresponding Vanderbilt Coordinating Center's (VCC's) Clinical Trial Site Manager as needed throughout a study's lifecycle.
May assist Clinical Research Site Managers or Clinical Research Navigators with study start-up activities including system set-up, monitoring plan creation, database construction and study tracking.
Maintains effective working relationships with study team, study PI, and participating sites. Consults with other VCC employees to solve operational or data problems.
Assists with the assessment of a project's status, task completion, and staff productivity in order to keep study milestones on track. Determines status of incoming data, site responsiveness, need for the development of a customized action plan in order to address and prevent issues, and the need for additional support from leadership within the VCC, other VUMC departments, or within the external participating sites in order to solve outstanding issues.
Generates data retrievals and summaries and performs data analysis as needed for Clinical Trial Site Managers, study Principal Investigators, Steering Committees, Safety Monitors, and for Data Safety Monitoring Boards.
Validates clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
Possesses an eagerness to learn about the many diverse therapeutic areas, both surgical and medical, supported by the VCC.
Collaborates with research informatics within VICTR and the VCC in an effort to develop new functionality and electronic applications to support data management when novel approaches are required in order to operationalize a new study or to support general workflow across the VCC.
Reviews electronic case report forms for completeness and consistency. Queries data inconsistencies and revises case report forms in compliance with standard operating procedures as needed. Reviews and approves postproduction changes to active study databases in order to control study documentation and workflow.
Implements strategy for data cleaning and the design and programming of study databases. Prioritizes work in line with project management decisions.
Maintains a thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
May attend internal and external project meetings in order to provide input from a CRA2 perspective. May provide input to the study PI and sponsor as needed when issues surrounding data management are negatively impacting a study's progress.
Serves as a valuable resource to other VCC colleagues for data management best practices and tools. May develop and give internal and external presentations in order to increase education and awareness of proper data management and project management techniques.
Remote and On-Site Monitoring Responsibilities
Ensure study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study with Clinical Trial Site Manager support
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements with Clinical Trial Site Manager support
Ensure the resources of the funder and Vanderbilt University Medical Center are spent wisely by performing the required monitoring tasks in an efficient manner according to established SOPs and guidelines
When traveling will adhere to all applicable policies and guidelines of Vanderbilt University Medical Center including managing travel expenses in an economical fashion and preparing accurate and timely trip reports
Assist in recruitment/review of investigators, collecting study documentation
Update, track and maintain study-specific trial management tools/systems
Generate and track investigational product shipments and supplies as needed
Attend investigator meetings, project team meetings and teleconferences as needed
Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties.
Assist with site/study audit preparation and follow up on Corrective Action Plan responses as needed
Provide Coverage for other CRA2 within VCC
Perform other duties as assigned by management
About the Department:
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt's virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center's Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/ .
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. It is a place 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.
VUMC Recent Accomplishments:
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments.
US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
The Leapfrog Group: grade "A" in Hospital Safety Score
National Institutes of Health: among the top 10 grant awardees for medical research in the US
Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
Nashville Business Journal: Middle Tennessee's healthiest employer
American Hospital Association: among the 100 "Most Wired" medical systems in the US
Additional Information :
This is a term position. 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. This position may also have the opportunity to work remotely.
We have several people within VCC without Bachelor's - want to confirm that experience is still allowable if equitable to the Bachelors degree? I wouldn't want to hold this against or disqualify a great candidate due to lack of a degree
Internal Number: 2009345
About Vanderbilt Health
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. 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.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.