TI Clinical Research Assistant 2
Full Time
Portland, OR 97239
Posted
Job description
Department Overview:
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.
Therapeutic Intervention Clinical Research Assistant 2 position in the Parkinson Center and Movement Disorders Program, 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. Primary work location is on campus, interacting with research participants and research study data.
Function/Duties of Position:
- 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: coordinated scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services; assuring completion of study assessments and procedures per protocol; obtain informed consent; laboratory sample collection, processing, storage, and shipping; conducting and/or assisting with study procedures such as collection of vital signs, ECGs, lumbar punctures. Assist Program 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, the OHSU Institutional Review Board (IRB), 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, in compliance with Good Clinical Practice guidelines; assist with regulatory submission 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 Parkinson Center, and other tasks as assigned.
- Education & communication: preparation for and participation in weekly clinical research coordinator team and 1-on-1 meetings; monitoring of changes to university and industry standards for clinical trials compliance.
- Bachelor’s in relevant field OR Associate’s 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
- Ability to stand and walk throughout the OHSU campus for long periods of time during study visits
- 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
Please include a cover letter.
All are welcome: 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.
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