Clinical Research Data Specialist - Remote

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. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness 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.

Organization:

VICC - Clinical Trials 160

Job Summary:

Manages the data functions and the conduct of research protocols under occasional guidance. Ensures the integrity and quality of clinical research is maintained.

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KEY RESPONSIBILITIES
• Inputs, reviews and submits eligibility and supporting documentation into data capture systems for a portfolio of studies.
• Identifies adverse events from electronic medical records, and provides support to correctly and completely record them. Assists with trending reports on adverse events for each trial and across teams.
• Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
• Reviews and approves responses to sponsor queries, supports complex queries and works with sponsors on issues.
• Oversees the monitor scheduling and meets with monitors to review data, answer questions, and resolve queries.
• Queries research team to clarify, reconcile and complete data issues. Identifies and resolves discrepancies per protocol.
• Acts as a preceptor for staff
• 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.
• 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
• Data Analysis (Intermediate): The ability to analyze data in an accurate manner.
• Data Entry (Intermediate): The ability to transcribe information from the original source into an electronic system according to written and verbal instructions efficiently and accurately.
• Project Management (Intermediate): Planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives.
• Problem Solving (Intermediate): 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.
• 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.
• Quality Assurance (Intermediate): 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.
• Database Knowledge (Intermediate): Knowledge and understanding of a database and how data is organized so that its contents can easily be accessed, managed, and updated.

Our Academic Enterprise is one of the nation’s longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

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.

Aligning with Vanderbilt Health’s Strategic