TI Clinical Research Assistant

TI Clinical Research Assistant

US-OR-Portland

Requisition :

Position Category: Research

Job Type: Research

Position Type: Regular Full-Time

Posting Department: Neurology Department

Posting Salary Range: $48,734-$77,522

Posting FTE: 1.00

Posting

Schedule:

M-F

Posting

Hours:

Typical hours between 8am and 5pm

HR Mission: School of Medicine

Drug Testable: Yes

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 led 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 Coordinators (TI Clinical Research Assistants) are highly organized and are responsible for duties related to the implementation of human subject research protocols. 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.

• 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 general 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.
• Collaboration with the clinical research billing office to ensure accuracy and completeness.
• Assisting with routine correspondence with the OHSU IRB and industry sponsor IRBs related to required submissions, protocol modifications, and continuing reviews.
• Assisting with regulatory document and binder maintenance in compliance with Good Clinical Practice (GCP) standards.
• 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.
• 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 to serve as a backup for other Layton Center clinical trials Clinical Research Coordinators (Clinical Research Assistants) to provide coverage for time off.
• May assist with onboarding and training of other staff as needed to ensure study participant safety and study continuity.

• Bachelor’s degree in relevant field; OR Associate’s degree AND 2 years of relevant…