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CLINICAL TRIALS ASSISTANT II
Job Title: CLINICAL TRIALS ASSISTANT II
Job Code: 0052
FLSA: N
Job Level: 08
Revised Date: 12/01/2007
Job Family: JF 05
Occupational Summary
Perform a variety of research, data base and clerical duties of a complex and technical nature in support of multi-center clinical trials to ensure adherence to protocols and quality of information received.
Work Performed
Perform a variety of research, data base and clerical duties of a complex and technical nature in support of multi-center clinical trials to assist investigators in organizing, gathering and compiling clinical research data.
Maintain and update site demographics on computer data base; log forms received and file as appropriate; prepare reports from data base to include weekly reports and other reports as requested.
Supervise the receipt and dissemination of study related regulatory documents and correspondence from assigned sites; screen documents for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of data.
Maintain ongoing communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines; ensure that study materials and drug kits are shipped and resupplied as requested; respond to questions related to study protocol independently or refer to others as appropriate; document all conversations in the data base.
Assist Clinical Trials Coordinators in general administrative activities as requested to include, but not limited to, providing input on adverse trends or problems noted and/or input regarding study modifications, development of Standard Operating Procedures for clinical trials and revision of data collection forms and worksheets; discuss unusual requests or indications that a site is not in compliance with established guidelines.
Communicate regularly with regional data monitors as needed to provide information before and after visits to participating sites; review the monitor's post visit reports and follow up on problems identified as appropriate.
Communicate and coordinate with other study personnel as required to include data entry and randomization personnel, pharmacy, laboratories, study sponsors and others as needed for study implementation and problem resolution.
Attend routine weekly meetings and other meetings related to the clinical trial; stay abreast of information and any changes to study protocol.
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 knowledge of basic mathematical, data collection and research principles normally acquired through an AA/AS degree.
Experience
Work requires two years directly related experience in clinical trials research; or three years general research experience. Perform a variety of research, data base and clerical duties in support of multi-center clinical trials.
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.
