Clinical Research Coordinator at Oregon Health & Science University

Portland, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Coordination, Therapeutic Interventional Trials, Protocol Adherence, Participant Safety, Recruitment, Informed Consent, Laboratory Sample Processing, Data Entry, Regulatory Compliance, Good Clinical Practice, IRB Submissions, Case Report Forms, Electronic Data Capture, Communication, Attention To Detail, Task Management

Industry

Higher Education

Description

Function/Duties of Position The Division of Movement Disorders has an opening for a TI Clinical Research Assistant 2 (Clinical Research Coordinator). The Clinical Research Coordinator is a highly organized and motivated individual responsible for coordinating multiple complex therapeutic interventional trials related to Parkinson's Disease and Movement Disorders. The coordinator will perform study procedures per the research study protocols and regulatory requirements, while adhering to study protocol timelines and working closely with the 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: 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 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, 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 trainer, 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 changes to university and industry standards for clinical trials compliance. Required Qualifications Bachelor’s degree 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. 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 Additional Details Working Conditions: 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. Physical Demands: Ability to stand and walk throughout the OHSU campus for long periods of time during study visits. Please include a resume and cover letter with your application. 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.

Responsibilities

The Clinical Research Coordinator is responsible for coordinating multiple complex therapeutic interventional trials related to Parkinson's Disease and Movement Disorders, ensuring study procedures are performed according to protocols and regulatory requirements while prioritizing participant safety. Key duties include managing recruitment, conducting study visits, maintaining regulatory documents, and ensuring timely and accurate data entry into electronic systems.