PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
In collaboration with the VU Human Research Protections Program, the Research Services Consultant II (RSC II) assists with the optimal application of the Federal, State, and local laws, guidance documents, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VU research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The RSC II researches topics of departmental, institutional or strategic importance.
Under the supervision of the Coordinating Center Manager within the Clinical Trials Shared Recourses Coordinating Center, the Research Service Consultant II supports the clinical research efforts of the Vanderbilt-Ingram Cancer Center by providing oversight and project management for participating sites of our Investigator Initiated Trials, in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and Medical Center policies and procedures.
The NCI-designated Vanderbilt-Ingram Cancer Center (VICC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care. VICC provides research resources to its engaged faculty and offers multidisciplinary cancer care to its patients.
Responsibilities related to project coordination activities include independently managing start-up activities at the sponsor level, inclusive but not limited to, finalizing protocols for sponsor-investigators, submitting to internal and external committees (Food and Drug Administration [FDA], Scientific Review Committee [SRC], etc.) and funders. The setup and activation of outside vendors such as drug-depots and laboratories.
Additionally, the incumbent will be responsible for managing all components of the multi-site protocols. S/he will be responsible for developing protocol specific multi-site processes, checklists and templates for both standardization and ensure compliance with federal, state, and university regulations for the management and coordination for all investigator-initiated trials with sub-sites in collaboration with the Coordinating Center Manager.
In addition, the Research Service Consultant II serves as the liaison to investigators, funders, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team Meetings, interacting with funding agencies including National Cancer Institute, and compliance and regulatory groups such as the Food and Drug Administration (FDA).
The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).
Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.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.
Additional Key Elements/ Responsibilities:
Serves as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Participates and leads institutional activities regarding culture and regulatory issues related to research.
Monitors and analyzes new legislation, Federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community.
Provides expertise to departments, institutional committees, Investigators, research staff, and students on procedures and operating practices for the research community on human research protections and good clinical practices.
Interfaces and partners with regulatory bodies who influence policies and regulations that affect research.
Establishes and maintains communications with institutional committees, Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research.
May represent the research community on various advisory and operating committees, as appropriate.
Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budgets, process improvement plans, and efficient time lines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols as appropriate.
Guides Investigators and key study personnel in the development of protocols and study budgets to capture all study costs and compliance with regulations; and assures adherence to FDA and other regulatory guidelines.
Develops and implements training programs on the strategic application of IRB policies and procedures, Federal mandates and guidelines, NIH, GCP/ICH guidance, and other applicable topics (e.g. budget development, research billing, grants, contracts, COI) for the VU Human Research Protections Program.
Critically analyzes current research practices and policies through observation, data collection, peer reviews, interviews, and industry analysis to assess quality of existing workflow processes and identify improvements needed to maximize quality and efficiency of human research protections programs.
Analyzes cost estimates and budget requests developed for planning and projecting human research protections program activities.
Assists with the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.
Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise.
Develops and implements quality assurance and regulatory strategies for the VU research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements, and recommends to the appropriate departmental officials activities and resources required to support this strategy.
Defines, establishes, and assures compliance with all internal standard operating procedures consistent with Federal standards for designing, conducting, recording, and reporting research within the Research Enterprise.
Provides ongoing assistance, consultation, and education to research personnel regarding quality assurance audits; clarifies data discrepancies and deviations from standing operating procedures. Analyzes results and assists in the development of a preventive action plan for potential future discrepancies.
Designs and develops audit measures based on general standard operating procedures and prepares checklists for inspections and compliance monitoring.
Conducts internal and external audits of research at periodic intervals to identify and analyze data errors, data discrepancies, process errors, and deviations from study protocols to assure compliance with applicable regulatory requirements and standard operating procedures.
Promotes compliance through detection, resolution, and reporting of research activities that do not conform to Federal, State, and local laws, Institutional policies and procedures.
Performs statistical analysis to identify data discrepancies and to determine error rates/trends; develops, prepares, and presents audit reports, as required.
Responsible for the comprehension, management, and facilitation of IRB regulatory assurance(s), contracts, agreements, and IRB policies and procedures.
Monitors and reports developments regarding Federal, State, and local laws, and research enterprise policies and procedures that impact institutional initiatives.
Manages and develops effective working relationships with customers by seeking, interpreting, and responding to feedback. Contributes to developing standards of conduct and feedback methods.
Monitors the development, approval, periodic review, revision, interpretation, version control, and historical archival to prevent inconsistencies and discrepancies of VU research community, programs, and departmental procedures, assurances, contracts, and agreements.
Develops, implements, and documents meaningful educational activities for IRB Staff, IRB Committee Members, VU Administration, and VU Principal Investigators in conjunction with Team Leaders. Responsible for creating and implementing IRB professional development plan and budget.
Assists and provides guidance for the research enterprise with budget development, analysis, financial risk assessment, billing compliance, and grant writing support in adherence to regulatory requirements.
Assists investigators with developing effective tools to successfully conduct a research protocol analysis related to study costs and risk assessment.
Assists with the performance of Medicare Deemed (all applicable criteria met) trial assessment.
Actively demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.
Communicates and models values and mission of VUMC. Exhibits personal integrity and respect for others.
Treats all team members as unique individuals with valuable resources and skills that enhance the team.
Collaborates with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
Assures self-goals are aligned with departmental goals for success.
Takes responsibility for mistakes or bad decisions and learns from mistakes.
Accepts responsibility for improvement of one's performance through recognition of strengths and weaknesses, participation in professional development activities, and positive input in team growth.
Effectively participates and leads project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvement.
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.