Associate Clinical Research Data Specialist

Associate Clinical Research Data Specialist

• 2205771

Associate Clinical Research Data Specialist

Job Summary:

Monitors the data functions and the conduct of research protocols with some guidance. Ensures the integrity and quality of clinical research is maintained.

Department/Unit Summary:

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/

Position Shift:

• Days

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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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

Additional Key Elements/ Responsibilities:

• Inputs, reviews and submits eligibility and supporting documentation into the data capture systems for a portfolio of studies.
• Identifies adverse events from electronic medical records, and provides support to correctly and completely record them.
• Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
• Queries research team to clarify, reconcile and complete data issues. Identifies and resolves discrepancies per protocol.
• Prepares for and participates in internal and external clinical trial audits.
• Assist with registration and dispensation of clinical trial product using IVRS, IXRS, or IWRS.
• Maintaining appropriate and complete documentation of case report forms or electronic case report forms.
• Identifies and reports deviations for each trial.
• Reports metrics from given study load, including timeliness of entry and outstanding data.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES:

REGULATORY COMPLIANCE (NOVICE): Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.

DATABASE KNOWLEDGE (NOVICE): Knowledge and understanding of a database and how data is organized so that its contents can easily be accessed, managed, and updated.

DATA ANALYSIS (NOVICE): The ability to analyze data in an accurate manner.

DATA ENTRY (NOVICE): The ability to transcribe information from the original source into an electronic system according to written and verbal instructions efficiently and accurately.

QUALITY ASSURANCE (NOVICE): Understands the goal of increasing organizational productivity and individual performance by making the products and services within your work assignments more efficient and more effective.

PROJECT MANAGEMENT (NOVICE): Planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives.

PROBLEM SOLVING (NOVICE): Uses critical thinking and process improvement i.e. coaches and mentors development of problem statement, describes current state, identifies root causes, creates future state, coaches and mentors development of solutions and action plans with a sustainability plan. Applies appropriate tools to address issues.

CORE ACCOUNTABILITIES:

• Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance.
• Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement.
• Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements.
• Team Interaction: Individually contributes to project/ work teams.

CORE CAPABILITIES:

SUPPORTING COLLEAGUES:

• Develops Self and Others: Continuously improves own skills by identifying development opportunities.
• Builds and Maintains Relationships: Seeks to understand colleagues' priorities, working styles and develops relationships across areas.
• Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner.

DELIVERING EXCELLENT SERVICES:

• Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service.
• Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner.
• Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support.

ENSURING HIGH QUALITY:

• Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.
• Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond.
• Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.

MANAGING RESOURCES EFFECTIVELY:

• Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service.
• Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources.
• Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.

FOSTERING INNOVATION:

• Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.
• Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action.
• Adapts to Change: Embraces change by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Position Qualifications:

Bachelor's Degree (or equivalent experience) Research, Medical or related area and < 1 year experience

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.

Sensory

• 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.