CLINICAL RESEARCH SPECIALIST, SR

Operations: Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. 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. Under supervision, collects information from sources including the EHR to assist study team in determining eligibility. Follows SOPs. Under supervision, 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: Under supervision may collect information about AEs, identified in the protocol or investigator brochure. 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. With supervision, responds to queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. 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 reports on study progress for the PI and other study team members and collaborators. Science: May assist with simple literature searches under supervision from PI or CRC. 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. Prepares studies for closeout and document storage. May train or oversee others. Leadership: Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively 

with others, regardless of reporting relationship, to accomplish shared work objectives. Description of Portfolio Responsibilities: (Effort .%): Description of Clinical Responsibilities: Clinical responsibilities: • Type of Research: This position involves working in the division of Pediatric GI. The research involves work on trials that are Investigator initiated, government funded, or industry funded. The trials are phase I-IV. Special skills: Must have good organizational and communication skills.