Clinical Research Data Specialist - Hybrid in Nashville TN

Vanderbilt University Medical Center•Nashville, TN

1d•Hybrid

About The Position

Vanderbilt University Medical Center (VUMC), located in Nashville, Tennessee, is a global crossroads of teaching, discovery, and patient care. VUMC is a community dedicated to changing the world, valuing expertise, expanding knowledge, and challenging abilities. Vanderbilt Health is committed to fostering an environment where everyone can thrive, celebrating uniqueness, and encouraging employees to take pride in their work and continuously strive for improvement. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research. This specific role is within the VICC - Clinical Trials 160 organization. The Clinical Research Data Specialist manages the data functions and the conduct of research protocols under occasional guidance, ensuring the integrity and quality of clinical research. The Academic Enterprise at Vanderbilt Health is one of the nation’s longest-serving and most prestigious academic medical centers, cultivating distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care. The Office of Research supports this environment by providing shared resources, administrative expertise, and professional guidance to foster discovery and training.

Requirements

1+ years of Oncology research experience
Healthcare or clinical background with familiarity in medical terminology
Experience in administrative support or customer service roles
Transcription experience with attention to accuracy and detail
Proficiency in basic data entry and information management
Strong general computer skills and comfort working in multiple systems
Experience with scheduling, document management, and electronic filing
Professional communication skills, including coordination with external departments and stakeholders
Experience uploading and managing clinical or diagnostic imaging
Strong teamwork and collaboration skills in a fast-paced environment
Excellent organizational skills with the ability to manage competing priorities
Proven ability to multitask while maintaining accuracy and quality
Proficiency with Microsoft Office Suite, including Teams and Excel
Experience working with EPIC or other electronic medical record (EMR) systems
Familiarity with electronic data capture (EDC) systems, such as Medidata Rave
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.
Bachelor's degree

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.