Clinical Research Associate 2

Clinical Research Associate 2 - VCC - VICTR

JOB SUMMARY

This position is responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, conduct of research protocols, and data management functions, such that the clinical research is maintained and the integrity and quality of the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure, and research protocols.

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/ .

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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. 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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.

* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.

* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.

* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.

* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows

* Magnet Recognition Program: Received our third consecutive Magnet designations.

* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement

* Human Rights Campaign Healthcare Equality Index: 6 ^th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

KEY RESPONSIBILITIES

• Ensure compliance with clinical trial protocol, check clinical site activities, make on-site visits, review case report forms (CRFs), and communicate with clinical research coordinators.
• Assure the protection of the rights, safety and well-being of human study subjects.
• Ensure that the scientific integrity of the data collected is protected and verified and that adverse events are correctly documented and reported.
• The responsibilities listed are a general overview of the position and additional duties may be assigned

TECHNICAL CAPABILITIES

DATA MONITORING (INTERMEDIATE)

- Perform remote and in certain cases on-site monitoring responsibilities and assessment of site performance. Ensure accuracy, validity and completeness of data collected. Query research team to clarify, reconcile and complete data issues. Ensure patient safety is maintained and informed consent procedures are carried out. Provide training and update investigative site team of any changes in study conduct and documentation requirements. Review clinical data, source documentation, CRF, and investigative site regulatory files, ensuring continued acceptability of the investigator, clinical site team and facility. Contribute to the expeditious completion of study procedures and data collection. Build and maintain relationships between multi-sites and VUMC.

REPORTING & DOCUMENTATION (INTERMEDIATE)

Fully document trial related monitoring, including clinical study progress. Ensure site IRB approval is current and all IRB documentation is in order. Ensure that all AEs are reported within the required reporting timelines, documented as appropriate, and consistent with all data collected and with the information in the source documents. Promptly communicate relevant status information and issues to appropriate stakeholders. Write and distribute monitoring visit reports and any supplemental documents/reports to all sites for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to investigators and their teams. Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.

QUALITY ASSURANCE (INTERMEDIATE)

- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Review case report forms and query generation and resolution against established monitoring plan guidelines. Act as a liaison with vendors such as central laboratories as required to ensure protocol adherence.

PROJECT ADMINISTRATION (INTERMEDIATE)

- Assist in recruitment and review of investigators, collecting investigator and site management documentation. Update, track and maintain study-specific trial management tools and systems. Ensure investigational product accountability accuracy, oversee investigational product inventory, and generate and track drug shipments and supplies as needed. Attend investigator meetings, project team meetings and teleconferences. Provide timely study updates as needed to all applicable site personnel. Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties. Act as preceptor for clinical trials staff.