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CLINICAL RESEARCH SPECIALIST
Job Title: CLINICAL RESEARCH SPECIALIST
Job Code: 4029
Job Level: D2
Revised Date: 06/27/2005
Supervisory Responsibility: No
General Description of the Job Class
Perform a variety of research, data base and clerical duties of a routine and technical nature in support of multi-center clinical trials to ensure adherence to protocols and quality of information received.
Duties and Responsibilities of this Level
Perform a variety of research, data base and clerical duties of a routine 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.
Receive and disseminate study-related regulatory documents and correspondence from assigned sites; assist in screening documents for completeness and compliance with protocol and appropriate regulations; assist in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data. Assist in maintaining 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 re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to others as appropriate; document all conversations in the data base.
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 routine 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.
Required Qualifications at this Level
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.
Work requires one year experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Degrees, Licensure, and/or Certification
Knowledge, Skills, and Abilities
PC WORDPROCESSING SOFTWARE
PC DATABASE MGT SOFTWARE
Distinguishing Characteristics of this Level
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.