Duke University CLINICAL RESEARCH SPECIALIST, SR - DUSON in Durham, North Carolina
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803 CLINICAL RESEARCH SPECIALIST, SR
Operations: Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Assist with maintenance of study level documentation. Define source document. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Prepare for study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics: Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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 to a subject as these pertain to your clinical trial
Data: Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis Train others on study team in use of technologies and software, and in completion of ECRFs. Assist with the development of data collection documents to standardize process. Use EDC systems and enter data accurately. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Assist with development of and follow SOPs for data quality assurance.
Science: Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
Leadership: Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.
Study and Site Management: Collect information to determine appropriate feasibility, recruitment and retention strategies. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage
Communication: Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. 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.
Description of Portfolio and Clinical Responsibilities: This position includes research within the Hispanic and Latino community and consists primarily with conducting interviews and collecting blood samples. This team member will work closely with the PI and other study team members to implement the study protocol with main roles to include screening, recruiting, conducting study visits, and data collection.
Special Skills • Applicants must be fluent in Spanish. • Basic phlebotomy skills preferred. • Study participants are recruited from the community and study visits will predominately be performed in participant's home. Job applicants need dependable transportation to travel to and from study visits; Mileage reimbursement will be offered.
• Ability to work evenings and/or weekends on a rotating basis.
CLINICAL RESEARCH SPECIALIST, SR - DUSON
Job Family Level:
Full Time / Part Time:
Regular / Temporary:
SON-FACULTY AND STAFF
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.
Work requires an associates degree.
One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).