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CLINICAL DATA SPEC I
Job Title: CLINICAL DATA SPEC I
Job Code: 2659
FLSA: E
Job Level: 11
Revised Date: 12/01/2022
Job Family: JF 05
Occupational Summary
The Clinical Data Specialist I (CDS I) provides support and assistance to the Lead Data Manager, carrying out assigned tasks to meet project needs and deliverables. The CDS I may perform higher level CDS responsibilities on a project or function as a lead clinical data specialist on uncomplicated projects in the maintenance phase.
The CDS I participates in a variety of independent activities involved in planning, organizing and conducting research studies for assigned projects, within the overall scope of the management function.
Work Performed
Project Management Responsible for data management project related tasks as designated by the Lead Data Manager. Makes recommendations to Lead Data Manager for improvement. Communicates effectively with project team members, including those from cross functional groups Adheres to project timelines and informs the Lead Data Manager when timelines are at risk.
Data Coordination Performs EDC account management on projects to include creation, activation, and deactivation, termination of sites and site user accounts, and release of account information. Helps troubleshoot and resolve project integration issues (e.g. developed tools such as SADI; data loading). Assists with troubleshooting and triaging project related issues. Maintains and updates the DCRI help desk issue management system (HDIMS) in support of EDC Support Services incidents. Assists with EDC database lock procedures. Provides support for internal and external audits as assigned by the Lead Data Manager. Assists with drafting and maintaining the Data Management Plan. Supports the Lead Data Manager with project documentation maintenance. Participates in meetings as designated by the Lead Data Manager. Assists with project lock activities. Maintains familiarity with knowledge of healthcare and research data that is collected in therapeutic area. Assists with data management project training. Assists with creating training materials.
Technical Collaborates in the development, programming and unit testing of prototype eCRF screens and data validation checks. Assists with creation and updating of specifications. Assists with testing of CDMS components and reports. Runs, reviews, and posts queries for quality control checks and listings; reviews, closes and/or reissues queries. Runs and distributes project reports. Trains project team members on project related tasks. Reviews project team members work and provides feedback. Participates in departmental initiatives. Participates in performance review via self-assessment, personal goal- setting and providing feedback about colleagues. Completes required departmental and project training; maintains a working knowledge of requirement trainings.
Required Qualifications at this Level
Education/Training
BA/BS Degree
Experience
Minimum of 2 years of directly related data management experience.
Skills
Position requires experience coordinating the work of others, leading small teams, and representing their function and coordinating with cross- functional teams.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
