|
Duke University Job Description: |
Job Title: CLINICAL TRIALS SPECIALIST |
Job Code: 0070 |
FLSA: N |
Job Level: 10 |
Revised Date: 01/06/1995 |
Job Family: JF 05 |
Coordinate and perform a variety of research and administrative activities required in the management of clinical trials research conducted by principal investigators at Duke University Medical Center; perform a variety of independent duties involved in the collection, documentation and compilation of clinical research data.
Coordinate and perform a variety of duties involved in the collection of data in support of clinical trials research studies, through clinical assessments, interviews and observation to include interpretation and documentation of data.
Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and inform supervisors as needed.
Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress.
Assist principal investigators and/or other members of the research team in the development of plans and protocols for clinical research studies; recommend modifications to existing procedures and techniques to meet the needs of the particular clinical trials research study.
Ensure distribution and maintain inventory of appropriate forms, supplies,equipment, laboratory samples and drugs required for execution of research protocol(s).
Review work of lower level personnel within designated areas and assist intraining new personnel. 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.
| Education/Training: | 1. Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or 2. Completion of a bachelor's degree plus a minimum of two years closely related research experience; or 3. Completion of an associate's degree plus four years experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. |
| 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.
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.