TI Sr Clinical Research Assistant

Oregon Health & Science University•Portland, OR

12d•Hybrid

About The Position

The Therapeutic Intervention Senior Clinical Research Assistant position is within the Epilepsy Division, Department of Neurology. This role is responsible for coordinating multiple complex therapeutic interventional trials with minimal supervision, ensuring adherence to study protocol timelines and participant safety in collaboration with the Principal Investigator. The position involves independently preparing and submitting regulatory packages to the IRB, assisting the Clinical Trials Manager with trial start-up requirements and invoicing, and frequently collaborating with internal and external vendors and departments to arrange necessary services for clinical trials.

Requirements

Bachelor’s Degree in relevant field AND 1 year of relevant experience OR Associate’s AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience
Clinical research coordination, including conduct of multiple complex clinical trials and regulatory document maintenance, in role(s) with minimal oversight
Experience using electronic medical records system(s)
Independent IRB submissions (initial submissions, modifications, &/or annual review)
Clinical skills, such as phlebotomy, specimen processing, ECG, & vital signs measurements
Knowledge of clinical research regulatory standards and guidelines
Extremely well-organized with high attention to detail
Able to efficiently manage multiple tasks and demands with competing deadlines
A self-starter, able to work independently while being effective and efficient
Enjoys collaborating with and supporting colleagues in a team environment
Excellent written and verbal communication skills

Nice To Haves

Experience using the Epic medical record system
Familiarity with the procedures of the OHSU Institutional Review Board
CITI (Collaborative Institutional Training Initiative) courses – Good Clinical Practice, Human Subjects Research, & Responsible Conduct of Research
SOCRA CCRP (Society of Clinical Research Associates Certified Clinical Research Professional)

Responsibilities

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 the duration of the study protocol.
Attendance at and participation in community outreach events.
Coordination of scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services.
Assuring completion of study assessments and procedures per protocol.
Obtaining informed consent.
Collecting, processing, storing, and shipping laboratory samples.
Conducting and/or assisting with study procedures such as collection of vital signs, ECGs, lumbar punctures, & skin punch biopsies.
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.
Ongoing maintenance of regulatory compliance and organization of all study documents and materials, adhering to Good Clinical Practice guidelines.
Independent preparation and submission of regulatory packages to local and central IRBs, including initial submissions, modifications, annual reviews, protocol deviations, and adverse event reports.
Assisting Clinical Trials Manager with clinical trial start-up, which may include site selection visits, IRB submissions, OnCore set-up, collaboration with internal and external vendors and departments, creation of case report forms, and other related tasks.
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.
Assisting Clinical Trials Manager with tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures.
Assisting in preparation of invoices.