Sr. Research Strategy & Program Specialist - VICTR

This is a full-time/non-exempt term position lasting six months to one year.

JOB SUMMARY

Independently serves as the primary resource on a very diverse portfolio of research projects. Provides bespoke consultations on available research services to internal VUMC faculty and staff members, as well as to external research colleagues. Initiates, develops, and maintains relationships with key central research contacts within various VUMC offices to facilitate the proper operation of research projects.

Department/Unit Summary:

The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.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

• Provide independent, intermediate research support consultation and services, including regulatory, quality assurance and operational support, to all levels of research colleagues.
• Effectively lead/manage low- to mid-level institutional or national projects that have tight timelines and limited visibility.
• Play a lead role in the conduct of all tasks and activities required to complete projects and may oversee project activities of team members.
• Collaborate independently with internal and external customers to evaluate current services for continual improvement and develop new research tools.
• Act as a "go-to" resource for internal and external colleagues with less experience.
• Educate the research community regarding resources available to clinicians and researchers to improve aspects of the research enterprise.
• Exhibit excellent interpersonal and communication skills in collaborating with internal and external customers.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

RESEARCH SERVICES (ADVANCED)

• Demonstrates advanced knowledge in advising and assisting researchers and clinicians on improving the quality of research and grants by identifying collaborators, connecting investigators with resources/funding opportunities, and developing tools to further the research enterprise. Has played a lead role in identifying barriers to optimal study execution and formulate, implement, and assess solutions to those barriers. Independently identifies resources needed for the timely & successful completion of research projects. Provides available resources for preparing grant proposals, identifying study funding, ongoing financial management safety committees, IRB submissions, scientific review submission, study feasibility, recruitment methods, data management, and study implementation. May assist in the development of study budgets and billing grids to facilitate capture of all study costs and compliance with regulations. May assist in the development of reports, manuscripts, and other strategies for dissemination of research findings.
• Collaborates with leaders on project planning and sets own objectives to deliver against responsibilities that have a direct impact on the near-term results of a low- to mid-level research project or program. Is familiar with key literature relevant to projects. Able to articulate how detailed tasks and assignments contribute to the broad goals of the organization.

REGULATORY SERVICES (INTERMEDIATE)

• Demonstrates comprehensive understanding of the optimal application of federal, state, and local laws, guidance documents, GCP/ICH guidelines, VUMC Institutional policies, and HRPP/IRB policies and procedures to meet the objectives of the VUMC and national research community. Has independently consulted on research and regulatory issues to identify solutions and develop improvement processes. Comprehends, manages, and facilitates IRB regulatory assurance(s), contracts, agreements, and IRB policies and procedures when appropriate. Tracks the progress of clinical research protocols through each step of the regulatory/administrative process and follows up as necessary to ensure efficient service when needed. Oversees coordination of ongoing analysis and modification of protocols and recommends amendments to study protocols, as appropriate. Assures adherence to FDA and other regulatory guidelines.

QUALITY ASSURANCE (INTERMEDIATE)

• Demonstrates proficiency in critically analyzing current research practices and policies through observation, data collection, peer reviews, literature reviews, interviews, and industry analysis to assess quality of existing workflow processes and identify improvements needed to maximize quality and efficiency. Able to independently develop and implement training programs on the strategic application of IRB policies and procedures, federal mandates and guidelines, GCP/ICH guidance, and other applicable topics (e.g., budget development, research billing, grants, contracts, COI). Independently provides ongoing consultation and education to research personnel regarding quality assurance.

OPERATIONAL SERVICES (INTERMEDIATE)

• Demonstrates proficiency in providing guidance on operational goals, business strategies, ethical considerations, regulatory mandates, and institutional practices, policies and workflow. Has assisted investigators, key study personnel, and other team members in the development of data tools, record keeping, study budgets, process improvement plans, and efficient timelines for research studies. Advises on the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.

TECHNOLOGY SERVICES (ADVANCED)

• Demonstrates advanced knowledge in broadening the institutional and national research community's exposure to available digital tools and products. Has provided consultation, training, education, and assistance on use of digital services. Collaborates with technical professionals to inform the build, maintenance, and enhancement of electronic platforms and systems to support the needs of clinical researchers and projects, as well as objectives of the research enterprise. Serves a key role in developing content and designing usability and accessibility to determine user experience.

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.

BASIC QUALIFICATIONS

• Bachelor's degree or equivalent experience (required)
• 3 years relevant experience (required)

Physical Requirements/Strengths needed & Physical Demands:

Movement

• Occasional: Sitting: Remaining in seated position
• Occasional: Standing: Remaining on one's feet without moving.
• Occasional: Walking: Moving about on foot.
• Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
• Occasional: Push/Pull: Exerting force to move objects away from or toward.
• Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
• Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
• Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

• Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
• Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
• Continuous: Communication: Expressing or exchanging written/verbal/electronic information.