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CLINICAL RESEARCH SPECIALIST
Job Title: CLINICAL RESEARCH SPECIALIST
Job Code: 0802
FLSA: N
Job Level: 07
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
Performs a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research, under the direction of a Clinical Research Coordinator (CRC) or similar Clinical Research Unit (CRU), Oversight Organization (OO) designee.
Work Performed
Research Operations
Under supervision, may document some participant-level information for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the electronic health record (EHR), collect information from sources including the EHR to assist study team in determining eligibility, and employ simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Follows standard operating procedures (SOPs) and strategies to manage and retain research subjects.
Assists with maintenance of study level documentation.
Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews.
Participates in study team meetings.
Safety and Ethics
Under supervision may collect information about adverse events (AEs), identified in the protocol or investigator brochure.
Data
Enters basic data for research studies. Scores tests and measures that do not require interpretation, according to the protocol.
With supervision, responds to queries created by a CRO or the data manager. May assist with quality control and data cleaning as directed. Under supervision, corrects and documents incomplete, inaccurate, or missing data for non-complex studies.
Follows SOPs for quality assurance and to assist in documenting and maintaining documentation to facilitate data sharing.
Follows required processes, policies, and systems to ensure data security and provenance.
Knowledgeable about the use of data standard policies.
Learns and uses new technology when required.
Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants and executes predetermined testing scripts after the completion of a build, or following any project changes or system upgrades.
Assists in updating reports on study progress for the PI and other study team members and collaborators.
Scientific Concepts
May assist with simple literature searches under close supervision from PI or CRC.
Site and Study Management
For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Leadership and Professionalism
Maintains Duke and project specific training requirements.
Communicates with other study personnel as required for study implementation and routine problem resolution.
Required Qualifications at this Level
Education/Training
Work requires an Associate's degree.
Experience
None above education listed above
Skills
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
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.
