CLINICAL RESEARCH SPECIALIST, SR - SON
CLINICAL RESEARCH SPECIALIST, SR - SON
SON-FACULTY AND STAFF
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. 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. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards. 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 UseElectronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. 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. Recognize when data agreements are necessary.
Science: Conduct literature reviews under the direction of the CRC, CRNC, or PI Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. Summarize study results.
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. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Prepare items for site initiation visits. Participate in sponsor required training 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 ina 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: Portfolio Management (Effort %): Clinical responsibilities:
• Type of Research This research project involves testing the effect of text messaging strategies hookah (i.e,. waterpipe tobacco) on behaviors and beliefs among young adults. Responsibilities include recruitment and screening of potential study participants, conduct of phone surveys, data entry and management, assist with fiscal management, IRB reporting, assisting with literature review, editing of papers and conference presentations, and serving as a liaison between Duke and off-site collaborators. The ideal candidate should feel comfortable with multi-tasking, working with multiple research teams, and will have experience working on tobacco related projects.
Special Skills Experience with clinical or behavioral research preferred.
803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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).
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.