TI Clinical Research Assistant

Therapeutic Intervention Clinical Research Assistant

Therapeutic Intervention Clinical Research Assistant position in the Department of Neurology. Responsible for coordinating multiple complex therapeutic interventional trials while adhering to study protocol timelines and working closely with Principal Investigator to ensure participant safety.

Recruitment & Retention: recruitment of research volunteers by determining interest and eligibility in accordance with study protocol; explaining complex study design and procedures in lay language to potential participants; creating recruitment materials; screening and enrolling eligible participants, and retaining participants for duration of the study protocol.

Study Coordination: coordinate scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services; assure completion of study assessments and procedures per protocol; obtain informed consent; collect, process, store, and ship laboratory samples; conduct and/or assist with study procedures such as collection of vital signs, ECGs, lumbar punctures, & skin punch biopsies. Assist Clinical Trials Manager in tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures. Effective and professional communication (written / electronic and verbal) with study team, study participants, sponsors, contract research organizations (CRO), investigators, local and central Institutional Review Boards (IRBs), and other departments at OHSU. Preparation for and coordination of monitoring visits by CRO and federal agency representatives.

Regulatory document maintenance: ongoing maintenance of regulatory compliance and organization of all study documents and materials, adhering to Good Clinical Practice guidelines; assist with regulatory submissions to IRB, including initial submission, modifications, and annual reviews.

Data Entry: timely, accurate completion of all required case report forms during study visits; entry of data into electronic data capture systems within sponsor-required timelines; timely resolution to data queries issued by sponsor and/or study monitor.

Additional Support: serve as trained, back-up study coordinator for other trials within the Movement Disorders Division and other tasks as assigned.

Education & communication: preparation for and participation in weekly clinical research coordinator team and 1-on-1 meetings; monitoring changes to university and industry standards for clinical trials compliance.

Primary work location is on campus, interacting with research participants and research study data. Occasional opportunities to work remotely. Working with human biological samples is required. In-person attendance at and participation in community events (approx. 6 per year), many of which occur on the weekend.

Required Qualifications

• Bachelor's degree (4 yr.) in relevant field, OR Associate's degree (2 yr.) and 2 years of relevant experience, OR 3 years of relevant experience, OR Equivalent combination of training and experience
• Demonstration of high level of attention to detail and organization
• Able to efficiently manage multiple tasks and demands
• A self-starter, able to work independently while being effective and efficient.
• Enjoys collaborating with, and supporting colleagues in a team environment
• Must possess excellent written and verbal communication skills

Preferred Qualifications

• Clinical trial and regulatory experience
• Experience with Epic or other electronic medical records system
• Familiarity with the procedures of the OHSU Institutional Review Board
• Clinical skills, such as phlebotomy, specimen processing, ECG, & vital signs measurements
• Clinical research coordination experience
• Experience working with a senior population
• Knowledge of clinical research regulatory standards and guidelines

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 View email address on click.appcast.io