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CLINICAL DATA SPEC II
Job Title: CLINICAL DATA SPEC II
Job Code: 2344
FLSA: E
Job Level: 71
Revised Date: 02/01/2016
Job Family: JF 05
Occupational Summary
Participate in a variety of complex, independent activities involved in planning, organizing and conducting research studies for assigned trials within the overall scope of data management function.
Work Performed
Participate in the development of data management protocols, case report forms (CRFS) and instructions, queries, procedure/in service manuals, project newsletters, project specific standard operating procedures and other data management tools for the assigned clinical trials.
Coordinate review teams within the data management section to generate, resolve, and track data queries to assure the integrity of the clinical data with respect to data guidelines and sponsor specifications; liaison with statistical analysis, programming, and clinical departments in identification and resolution of data management issues.
Provide feedback to data management section supervisor regarding quality assurance and information regarding detected deficiencies and corrective action needed; follow up with section supervisor until any deficiencies are resolved.
Prepare a variety of narrative and analytical reports and correspondence for data management section; monitor adherence to established timelines and recommend corrective action as necessary.
Develop study and educational material; conduct data management educational and/or monitoring visits to coordinating centers to assure standardized methodologies for CRF completion; assess centers adherence to protocols, recommend additional training as needed.
Provide training to lower level staff; participate in assessment of lower level staff competency and training needs as required; may review staff timesheets and recommend staffing and resource allocation.
Assist in the development and implementation of policies and procedures for the data management department as needed.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Work requires organizational, analytical and communications skills generally acquired through completion of a bachelor's degree program.
Experience
Work requires three years of directly related data management experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
N/A
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.
