Associate Clinical Data Specialist - Term, Peds Cardiology

Vanderbilt University Medical Center•Nashville, TN

2d•Onsite

About The Position

This position will manage data management for several of Dr. Jonathan Soslow's studies, including 2 R01s, a new DOD grant, and an Industry study. He/she will review eligibility of potential enrollees for the studies and communicate with the Research Nurse to increase enrollment in the studies. They will also coordinate data entry, data lock, and data monitoring ensuring the data is thorough and complete, matching the requirements of the study protocols. They will maintain case report forms, complete documentation of case reports, and identify deviations for Dr. Soslow's studies.

Requirements

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.
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.
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.
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.
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.
Project Management (Novice): Planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives.
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.
Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment.
Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.
Team Interaction: Provides informal guidance and support to team members.
Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences.
Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness.
Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring.
Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities.
Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative 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.