INTRODUCTION: Clin/Tran Research Coordinator III, series, and grade of the position , will work at the VA Tennessee Valley Healthcare System. The primary purpose of the position is to support the work of the investigators on a randomized, controlled trial that will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older Veterans discharged to skilled nursing facilities (SNFs).
MAJOR DUTIES :
Advanced knowledge and understanding of the planning, implementation and management of research operations. Responsible for planning and management of the approval, implementation and conduct of research protocols from planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, VA Policy and Procedure and research protocols. Serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, DSMBs and other research related entities. Functions as a departmental resource in research operations.
Design & Supervise Study Procedures and Protocols
Assists principal investigators in creating the detailed study protocols and procedures
Utilizes coordination skills to complete all research study protocols, including patient recruitment, screening, scheduling and organizing study visits, enrollment, assessments, interviews, medication tracking, and other protocol specific investigational procedures
Continually identifies areas for improvement within the clinical trial and revises operating procedures to assure quality and human subjects protection
Sets and tracks project goals and milestones, and modifies procedures appropriately to reach these targets
Train and Supervise Study Personnel
Assists principal investigators with hiring and training tasks
Instructs others in performing procedures for research as they are described in the protocol. Create study training materials and provide personnel in-services as needed
Communicates regularly and effectively with the interdisciplinary research team including the assignment of and prioritization of project tasks
Leads weekly team meetings and provide feedback on study efforts, problems, and protocols
Serves as a role model, mentor, and consultant
Maintains & Follows IRB and other regulatory protocols
Serves as an advocate for protection of human subjects by establishing and maintaining communication with investigators, research staff, sponsors, participants and representatives of professional organizations through ongoing monitoring of trial processes and participants
Maintains an advanced knowledge and understanding of policies, procedures, and regulations governing human subjects' research and incorporates them into the study protocol and procedures.
Proficiently and compliantly maneuver through the approval processes; ensures compliance of study personnel with training and procedures
Accurately and compliantly maintains documents required to be kept current and available for regulatory authorities and/or sponsor, prior, to during, and after the conduct of the trial
Participates in periodic site visits from sponsor, regulatory authorities, and others to review research source documentation and research procedures
Utilizes or acquires knowledge of intervention effects to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, DSMB, sponsor)
Data Management and Analysis
Participates in the development of data collection tools
Designs and maintains VA REDCap and SPSS databases
Performs data quality assurance reviews to maintain the integrity of data
Conduct descriptive data analyses for regular team feedback, study monitoring, and/or manuscripts and grant applications
Prepare data files for study biostatistician
Abides by rules of confidentiality for data management of sensitive medical information for study participants
Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data
Budget and Supplies
Identifies and procures equipment and supplies needed to fulfill project requirements
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 agency
Contribute to Research
Assist with manuscript preparation
Participate in grant making activities
Present research study to various audiences (i.e., acute care staff, SNF staff, professional organizations, etc.)
Continuing Education and Professional Activities
Engages in a minimum of 15 hours of continuous, job-related educational activities annually or pursing an advanced career-related academic education or certification
Participates in research related programs offered at the VA and/or Vanderbilt. Participates in groups within the institution to contribute to the improvement of the research environment
Actively seeks new learning opportunities. Develops and achieves both personal and professional goals
Networks with other research departments and colleagues to share best practices
Factor 1- Bachelor's degree in any of the following fields is strongly preferred: behavioral/social sciences (psychology, sociology, social work, gerontology) or medicine/health (pre-med, nursing). Candidates should have an interest in aging, quality of care/ quality improvement, or pharmacy.
· 5 years experience required
· Previous experience working directly with older adults in a health care setting is an asset
· Must have excellent organizational skills and be detail oriented
Factor 2 - Work is assigned by the investigators, who are located at the Vanderbilt Center for Quality Aging, to the employee. The employee will create and follow all standardized study protocols. The employee will assist principal investigators with hiring and training of study staff, instruct study staff on performing procedures for research as described in the protocols. The employee must follow rules of confidentiality for data management of sensitive medical information for study participants. The employee's work will be reviewed by the investigators on a regular basis. The employee will lead the weekly team meetings. Under the guidance of the investigators, the employee will continually identifies areas for improvement within the study and revises operating procedures to assure quality and human subjects protection. The employee will be able to seek new learning opportunities, participate in grant writing activities, and present research to various audiences with supervision from the investigators.
Factor 3 - Guidelines: The employee will follow the established, standardized protocols for the study. The employee is encouraged to discuss adaptations to the protocols with the investigators prior to undertaking. The employee will be set and track study goals and milestones, and be able to modify procedures appropriately to reach these targets.
Factor 4 - Complexity: The employee will be asked to complete a variety of complex tasks related to the study. S/he will utilize coordination skills to complete all research study protocols, including patient recruitment, screening, scheduling and organizing study visits, enrollment, assessments, interviews, medication tracking, and other protocol specific investigational procedures. The employee will maintain an advanced knowledge and understanding of policies, procedures, and regulations governing human subjects' research and incorporates them into the study protocol and procedures. The employee will be actively participating in data management and analysis, be a steward of budget and supplies, and seek a minimum of 15 hours of continuous, job-related educational activities annually or pursing an advanced career-related academic education or certification. Given the time sensitive nature of data collection, the employee must be able to accommodate variable work hours, not to exceed 40 total hours per week and confined to weekdays only.
Factor 5 - Scope and Effect: The research focuses on developing innovative interventions to improve quality of care and quality of life for older adults in a variety of care settings including hospital care, assisted-living, post-acute care and long-term care. The proposed randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older Veterans discharged to skilled nursing facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and discontinued medications, based on a combination of clinical criteria and patient preferences. We will evaluate the effects of the intervention on the total number of medications prescribed to Veterans at hospital and SNF discharge and at home 90-days after SNF discharge along with the prevalence of eight geriatric syndromes, medication adherence, and functional health status.
Factor 6 - Personal Contacts: The employee with have contact with older adult patients and/or surrogates, pharmacy staff within and outside the organization, medical records staff, clinic and hospital staff within and outside the organization, and skilled nursing facility staff. Additionally, the employee will have contact with the entire study team, office administration, and researchers both within and external to the organization.
Factor 7 -Purpose of Contacts: The employee will be contacting the above groups in order to carry out the work outlined in the study.
Factor 8 - Physical Demands: In the course of the work, the employee will need to be: sitting, bending, turning, walking, standing, lifting, pulling, pushing, and stooping. S/he will need to reach, grasp, and handle objects for the study. S/he will need have color recognition, depth perception, reading/close-up work, graphing, and calibration abilities. The employee will need to have fluent communication in English with the abilities to understand, respond, and translate into action what is communicated.
Factor 9 - Work Environment: The employee will work in an office environment at the Vanderbilt Center for Quality Aging as well as have contact with the acute care hospital on VA Tennessee Valley Healthcare System's Nashville campus.
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