TI Clinical Research Assistant

Oregon Health & Science University; Portland (OR); On-site; USD 55,000 - 75,000; Full time

Job summary

Oregon Health & Science University in Portland, OR, is seeking a Clinical Research Coordinator to support Layton Center Alzheimer's trials. You will recruit, screen, consent, and enroll participants, coordinate visits, and work with sponsors, CROs, and study teams to ensure protocol compliance.

This on-site role requires strong organizational skills, communication, and familiarity with regulatory standards; prior experience with EDC/EMR is a plus.

Qualifications

• Bachelor’s degree in relevant field; OR Associate’s degree AND 2 years of relevant experience; OR 3 years of relevant experience; OR Equivalent combination of training and 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
• Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers
• Able to perform the essential functions of the position with or without accommodation
• Must possess excellent written and verbal communication skills

Responsibilities

• 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, clinic space, infusion and/or imaging appointments.
• Coordinating with 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.
• Reporting adverse events to sponsors and IRBs.
• Data entry into study databases and EDC systems; responding to queries.
• Collection, processing, storage, and shipment of biological samples; inventory checks.
• Maintaining communication with study participants throughout the trial.
• Collaboration with billing office to ensure accuracy.
• Assisting with regulatory submissions and approvals.
• Maintaining regulatory documents per GCP standards.
• Ensuring protocol compliance and handling deviations.
• Participating in team meetings and trainings.
• Completing required CITI trainings in a timely manner.
• Backup coverage for other coordinators as needed.

Skills

Scientific methods & human subjects

Attention to detail

Communication & professionalism

Education

Bachelor’s degree in relevant field

Associate’s degree + 2 years experience

3 years relevant experience

Tools

MS Office (Word/Excel/Outlook)

Epic EMR experience

Job description

Department Overview

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.

Department Overview

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.

• Please include a cover letter with your application and resume.

Function/Duties of Position

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.

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 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 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.

Required Qualifications

• Bachelor’s degree in relevant field; OR Associate’s degree AND 2 years of relevant experience; OR 3 years of relevant experience; OR Equivalent combination of training and 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
• Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers
• Able to perform the essential functions of the position with or without accommodation
• Must possess excellent written and verbal communication skills

Preferred Qualifications

• Clinical research coordination experience preferred
• Clinical trial experience preferred
• Experience with Epic or other electronic medical records systems(s)
• Clinical skills including phlebotomy, specimen processing, ECG and vitals measurement, and/or neurocognitive test administration
• Experience working with seniors

Additional Details

• Typical schedule: M-F, occasional evenings and weekends, and international, national, local travel
• Work schedule may vary depending on job/study requirements
• This is an on-site position located at the Hatfield Research Center, OHSU Marquam Hill campus
• Travel between meeting locations including using the Portland Aerial Tram is required
• May have regular exposure to noise and interruptions
• Ability to stand and walk throughout the OHSU campus for long periods during study visits is required

Why apply to OHSU?

We are Oregon's only public academic health center.

In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.

All are welcome.

OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply.

To request reasonable accommodation, contact [e-mail]