CLINICAL RESEARCH SPECIALIST, SR

Operations: Assists with study level documentation and approvals for international studies. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings. Ethics: Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. Data: Enters and collects basic data for research studies. May score scripted or validated tests and measures. Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Documents and maintains documentation to facilitate data sharing during publication or study closeout. For non complex protocols, identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. 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. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades and may conduct some testing and documentation for Part 11 projects. Science: Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Provides some contribution to scientific publications or presentations (no authorship). Study and Site Management: As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). Leadership: Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Communicates with other study personnel as required for study implementation and routine problem resolution. 

Type of Research: This position will primarily support research within General Pediatrics, specifically the Duke Center for Childhood Obesity Research (DCCOR) group. The ideal candidate would be bilingual (English/Spanish), as a significant portion of the job will require the person to translate study materials, back-translate, enroll Spanish-speaking participants, and participate in study visits for those participants. Special skills: The ideal candidate would be bilingual (English/Spanish), as this position specifically requires translating/backtranslating study-related documents, such as informed consent forms, surveys, interview guides, instructions, etc. It also requires the person the enroll Spanish-speaking participants, and conduct study follow-ups with them.