TI Senior Clinical Research Assistant

Department Overview

This position supports industry-sponsored, NIH-funded, and investigator-initiated clinical trials in the Department of Dermatology, under the supervision of Alex Ortega, MD.

Duties include:

Under minimal supervision, coordinating complex therapeutic interventional clinical research protocols, and data management. Contributes to feasibility assessment and research protocol management. Assists with an audit of the billing grid against protocol-required tests and procedures to ensure accuracy and completeness. Ensures research protocol implementation. Collaborates with various OHSU departments to complete protocol-required tests and procedures, which may include the research pharmacy, Epic informatics team, clinical research billing office, and other areas.

Assists with billing review and charge reconciliation. Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Coordinates projects with active management of expectations, timelines, and deliverables through facilitation and coordination of steps, which may include multiple clinical research protocols. Tracks and reports milestones.

May assist leadership across multiple protocols to ensure appropriate and consistent project management, complex logistics, quality assurance, and participant safety. May lead data and regulatory audits of study conduct and data, emphasizing data security in concordance with federal, state, and local regulations.

Assists with trial start-up activities, including corresponding with the OHSU Institutional Review Board (IRB), eCRIS and ensuring all appropriate training and documentation is complete; recruiting, interviewing, and screening subjects for trials; following subjects throughout trial and follow-up period; ensuring all required data is collected and protocol is followed; reporting adverse reactions to trial sponsor and IRB, as appropriate; taking vital signs, performing ECGs, and drawing blood as required by the protocol;

performing sample processing and shipping; performing inventory checks and maintaining trial supplies; entering data collected from subject visits into the appropriate system for clinical trials; assisting with regular reporting of study updates to IRB and subjects, as applicable; attend meetings as directed by clinical trials investigators; additional duties may be assigned by clinical trials investigators or the Manager. May participate in onboarding and training new staff.

The duration of this appointment and indicated salary may be changed or eliminated if a gift, grant, or contract fund supporting this position becomes unavailable.

• Acts as the Department of Dermatology’s primary point of contact/trainer and provides project support, including expertise on available services from other OHSU and Dermatology units, for faculty, staff, and trainees designing and implementing clinical research studies (exclusive of industry-sponsored clinical trials); works closely with Clinical Trials Manager and industry-sponsored trial staff, Research Division Manager and staff, Outreach Manager and staff, Fiscal Manager, and other Dermatology teams to provide cohesive service to clinical researchers.
• Designs and coordinates IRB submissions for clinical research in the Department of Dermatology, including grant- and philanthropy-funded non-industry clinical studies and trials, tissue repositories, translational pilot projects, unfunded clinical investigator-initiated studies, and trainee projects (exclusive of industry-sponsored clinical trials).
• Provides study coordination for clinical studies, including coordinating patient visits, procedures, and schedules; rooming study patients and taking vital signs; managing CRFs; entering/managing data; drawing blood and processing lab specimens for shipment; assisting physicians and nurse practitioners with study-related procedures; and coordinating study subject payments (exclusive of industry sponsored-clinical trials). Provides project/clinical…