Clinical Research Associate Education & Compliance Coordinator ***REMOTE AVAILABLE***
Coordinates multiple clinical research education, training and compliance projects (including timelines, work plans, deliverables). Provides guidance and support in these areas and maintains alignment with strategic plan and vision. Partners with the leadership team to assess areas for improvement in clinical research practice.
This is a full-time/exempt term position lasting six months to one year.
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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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.
Effectively assists in planning, establishing and executing clinical research training programs according to regulatory guidance, laws and applicable policies in the research domain.
Provides onboarding and ongoing training to all staff.
Analyzes curricula to select the best methods to achieve desired performance and learning objectives.
Develops, implements, and monitors quality assurance SOPs and standards.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
EDUCATION & TRAINING (NOVICE)
Assist management team in planning and implementing orientation programs for new staff members on clinical research processes by (1) incorporating relevant policy into the orientation processes, (2) developing systems/processes to help staff meet competency requirements, (3) ensuring staff is competent in the process of subject recruitment, study enrollment, and follow-up for subjects that participate in research trials, and (4) utilizing available technology and other creative instructional strategies in orientation and ongoing education.
Coordinate and contribute to the preparation and delivery of clinical research training program content, instructional material, and format for delivery (in-service training, webinar, video, web, application help-text, etc.).
Assist with planning, implementation, evaluation and revisions of staff training in accordance with regulatory and area/hospital policies and procedures.
Identify educational needs based on audits and other information, and conduct training as needed.
Investigate and utilize available technology including web-based information in support of education/training programs.
Assist the lead educator in utilizing rapid instructional design tools and processes as well as adult learning theory and experience.
Advocate for staff education/development needs to the leadership team.
QUALITY ASSURANCE (NOVICE)
Actively participate in clinical research practice SOP development and revision including planning and implementing educational programs for new/changing technology.
Conduct formal and informal methods of evaluating program effectiveness including conducting learning assessments for individuals and groups.
Participate in developing written procedures for implementing new/changing technology and processes.
Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training and staff development for on-site and off-site personnel as required.
Maintain calendar and records for all training/professional development sessions. Assist with design and development of learning and educational training materials that include technologically innovative and instructionally sound deliverables to ensure effective and engaging learning.
Identify and participate in professional development opportunities from external sources.
Learn the research domain, regulatory guidance and laws, and applicable policies in order to effectively plan for, establish and execute clinical research training programs accordingly.
Develop and coordinate mechanisms to assure compliance with human subject protection guidelines.
Perform random, for-cause, and leadership-requested audits of clinical research studies as appropriate to ensure compliance with applicable regulations and guidelines.
Analyze data and prepare reports and summaries to present to leadership.
Maintain a current knowledge of federal and state laws, as well as VUMC regulations and guidelines governing human subject research.
Communicate with internal and external customers without requiring support and instruction from others.
Meet with leadership and customers to elicit clinical trials research training, education and compliance requirements.
Effectively communicate ideas and information to others, including non-technical audiences, in writing, with numbers, verbally and/or visually.
Share knowledge, ideas and information openly, effectively sell new ideas, and influence others.
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.
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.