CLINICAL RESEARCH SPECIALIST, SR
CLINICAL RESEARCH SPECIALIST, SR
Coop Clinical Rsch
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute's [DCI] Cancer Control and Population Sciences program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.
Clinical Research Operations
Screen participants, conduct and document consent for participants in minimal risk studies. Maintain subject level documentation. Schedule participants for study visits. Prepare necessary documents, equipment, supplies, and interviews according to study protocol and Standard Operating Procedures [SOPs].
Follow procedures and documentation of study payment. Assist with maintenance of study level documentation. Define source document.
Collect, prepare, process, ship, and maintain inventory of research specimens.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority. Identify and the explain the risk and benefits for a clinical trial.
Maintain Duke and project specific training requirements.
Use Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study data. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Run summaries and reports on existing data.
Follow SOPs for data QA. Use required processes, policies, and systems to ensure data security and provenance. Independently investigate incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.
Recognize and report vulnerabilities related to security of physical and electronic data.
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Actively participate in study team meetings.
And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
Bachelor's Degree is strongly preferred.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires an associates degree.
One year of relevant experience (e.g., research, clinical, interactionwith study population, program coordination).
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.