Duke University Job Descriptions

CLINCAL RESEARCH APPRENTICE

Job Title: CLINCAL RESEARCH APPRENTICE
Job Code: 0806
FLSA: E
Job Level: 09
Revised Date: 02/20/2025
Job Family: JF 05

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Occupational Summary

The apprentice will complete work based learning requirements and perform duties described below with guidance from their CRP mentor with increasing levels of independence over time.

Work Performed

Performs all responsibilities in a manner that demonstrates service excellence toward participants, principal investigators, colleagues, and other departments. Assumes responsibility for upholding the policies and procedures of the department and organization. The specific nature of the apprenticeship will reflect the needs of the sponsoring organization, the apprentices learning goals, and the priorities of the Clinical Research Unit (CRU) and study portfolio. Tasks will include those within and across the clinical research domains defined by the Joint Taskforce for Clinical Trial Competency, with increasing levels of independence over time.

Through mentorship and guidance from their CRP manager, apprentices will enhance their knowledge and develop foundational skills in clinical research through a combination of work based learning experiences in their unit and related instruction at Duke. Apprentices will build on their prior learning to demonstrate growing independence, competence, and confidence in performing assigned duties in the below areas.

Perform clinical research tasks under supervision, gradually increasing independence over time with guidance from a Clinical Research Professional (CRP) mentor.

Research Operations:

Document participant level information for studies. Collect and process information from sources, including the Electronic Health Record (EHR), to assist with participant eligibility. Conduct simple specimen handling procedures and maintain inventory. Assist with participant screening and recruitment according to study protocol. Prepares documents, equipment, supplies, etc., and assists with the conduct and documentation of study visits. Assists with maintenance of study level documentation. Follow SOPs for coordinating and retaining research participants. Under direct supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering) Assists with preparations for study monitoring and audit visits. Participates in study team meetings.

Safety and Ethics:

Understand and follow department level SOPs and GCP requirements for clinical research conduct. Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Assists with the development of consent plans and documents for participants. Assists in conducting and documenting consent for participants. May independently consent participants for non complex studies and under guidance for studies involving investigational products, devices, or clinical research orders.

Data:

Enters basic data for research studies. Scores tests and measures that do not require interpretation, according to the protocol. Under supervision, corrects and documents incomplete, inaccurate, or missing data for studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.

Scientific Concepts:

May assist with simple literature searches under supervision from PI or CRC.

Site and Study Management:

Assists in preparing for site visits. Assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). Associates patients with studies in CRMS, OnCore. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

Leadership and Professionalism:

Participates in work based learning and related instruction opportunities and applies knowledge and skills learned. Works with a mentor to identify growth areas and develop a tailored training plan. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Communicates effectively with study Attends key departmental meetings and communicates effectively with study team for study implementation and problem resolution.

Required Qualifications at this Level

Education/Training

Associate's degree in Clinical Research or successful completion of the approved Clinical Research Pre Apprenticeship program.

Experience

None.

Skills

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

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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.

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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.

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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.