The Layton Aging & Alzheimer's Disease Research Center, in the Department of Neurology at OHSU, is an NIH/NIA-funded Alzheimers Disease Research Center (ADRC). Layton Center investigative teams participate in national and international efforts to understand and develop treatments for Alzheimers 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 Alzheimers 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 Senior Clinical Research Coordinators (TI Senior Clinical Research Assistants) are highly organized and are responsible for duties related to the implementation of human subject research protocols. Senior Clinical Research 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 many other departments at OHSU, with study sponsors and contract research organizations (CROs), with vendors, and with study participants/volunteers.
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.
Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner.
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.
Training and Supervision:
Assisting with onboarding, training and supervision of clinical research assistants (CRAs), student workers, other staff, and volunteers.
Bachelor's Degree in relevant field AND 1 year of relevant experience OR Associate's AND 3 years of relevant experience OR 4 years of relevant experience OR equivalent combination of training and experience
Working knowledge of scientific methods and human subjects research
Intermediate or advance 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
Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers
Must possess excellent written and verbal communication skills
Ability to stand and walk throughout the OHSU campus for long periods during study visits
Clinical research coordination experience strongly preferred
Clinical trial experience strongly 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
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 [email protected]
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.
Bachelor's Degree in relevant field AND 1 year of relevant experience OR Associate's AND 3 years of relevant experience OR 4 years of relevant experience OR equivalent combination of training and experience
Working knowledge of scientific methods and human subjects research
Intermediate or advance 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
Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers
Must possess excellent written and verbal communication skills
Ability to stand and walk throughout the OHSU campus for long periods during study visits
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm
