The Layton Aging & Alzheimer's Disease Research Center, in the Department of Neurology at OHSU, is an NIH/NIA-funded Alzheimer’s Disease Research Center (ADRC). Layton Center investigative teams participate in national and international efforts to understand and develop treatments for Alzheimer’s disease and other forms of dementia. Layton Center teams conduct studies of promising treatments, technologies for patient support, genetics, neuroimaging and pathology.  

 

The Layton Center clinical trials team, based out of the Hatfield Research Center and lead by Dr. Aimee Pierce, implements a portfolio of Alzheimer’s and dementia trials in older adults. The trials include phase II, phase III, and phase IV trials, as well as observational studies.

Layton Center clinical trials team Clinical Research Regulatory Coordinators (TI Senior Clinical Research Assistants) are highly organized and are responsible for duties related to supporting human subject research trials, including various regulatory needs.  Regulatory Coordinators must effectively and professionally communicate (verbally including by phone and video call as well as in writing) within the Layton Center clinical trials team, with other departments at OHSU including the IRB, and with study sponsors and contract research organizations (CROs). 

 

Clinical Trial Coordination

• Recruiting, screening, consenting, and enrolling eligible participants/volunteers for interventional and observational clinical trials.
• Preparing for and coordinating in-person study visits including scheduling of study participants/volunteers, study staff (including physicians and nurses), of clinic space, infusion appointments, and/or imaging appointments under minimal supervision.
• Coordinating with OHSU research pharmacies and assisting with intervention administration.
• Assisting with and/or administration of neurocognitive assessments/tests.
• Collection and entry of study data on case report forms (CRFs).
• Collecting vital signs and blood; Performing EKGs/ECGs.
• Collection and timely reporting of adverse event (AE) data to study sponsors and Institutional Review Boards (IRBs).
• Data entry into study-specific databases and clinical trial electronic data capture (EDC) systems; Responding to EDC queries.
• Collection, processing, storage, and/or shipment of biologic samples (such as blood, urine, and cerebrospinal fluid); Study visit supply organization, inventory checks, and ordering.
• Maintaining communication with study participants/volunteers throughout the trial and follow up period.
• Assisting with study start-up activities, including correspondence with the OHSU IRB and industry sponsor IRBs; administration management in the OHSU clinical trials management system (eCRIS).
• Collaboration with the clinical research billing office to ensure accuracy and completeness; Assisting with billing review and charge reconciliation.
• Routine correspondence with the OHSU IRB and industry sponsor IRBs related to required submissions, protocol modifications, and continuing reviews.
• Regulatory document and binder maintenance in compliance with Good Clinical Practice (GCP) standards.
• Preparation for and coordination of monitoring visits. 
• Ensuring compliance with all protocol and regulatory requirements.
• Recognition of, documentation of, and communication about protocol deviations within sponsor and institutional guidelines.
• Attending, actively participating in, and providing updates at recurring Layton Center clinical trials team meetings.
• Assisting leadership with ensuring consistent project management, complex logistics, quality assurance, and participant safety.
• Must be willing and able serve as a backup for other Layton Center clinical trials Clinical Research Coordinators (Clinical Research Assistants) to provide coverage for time off.

Clinical Research Assistant, Student Worker, and Volunteer Training and Supervision

• Assistance with onboarding and training of clinical research assistants (CRAs), student workers, other staff, and volunteers.

Maintenance of Research, Ethics, Compliance, and Safety Training

• Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner. 

• Bachelor’s degree in relevant field AND 1 year of relevant experience OR Associate’s degree AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience
• Relevant experience must include regulatory activity experience
• Working knowledge of scientific methods and human subjects research
• Intermediate or advanced knowledge of Word, Excel, Outlook, and other MS Office programs
• Demonstration of high level of attention to detail; self-starter; ability to prioritize work demands and manage time appropriately
• Demonstrated high level of organization and ability to efficiently manage multiple tasks
• Able to perform the essential functions of the position with or without accommodation
• Must possess excellent written and verbal communication skills; be able to multi-task and enjoy working in a team

• Therapeutic intervention clinical trial experience strongly preferred
• SOCRA, CCRP or ACRP certification preferred
• Experience with Epic or other electronic medical records systems
• Clinical skills including phlebotomy, specimen processing, ECG and vitals measurement, and/or neurocognitive test administration
• Experience working with seniors

Please include a cover letter and resume with your application.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.


As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.