Clinical Research Data Specialist

3 weeks ago

Nashville, United States Vanderbilt Health Full time

Internal Number: R-21925

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 diverse 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 recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and 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.

Organization:

VICC- Clinical Trials 160

Job Summary:

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.

.

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.

, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

Core Accountabilities:

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.

Core Capabilities :

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e 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.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

1 year

Education :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled

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