TI Senior Clinical Research Assistant

Oregon Health & Science University•Portland, OR

16h•Hybrid

About The Position

This Therapeutic Intervention Senior Clinical Research Assistant position is within the Parkinson Center and Movement Disorders Division, Department of Neurology. The role involves coordinating multiple complex therapeutic interventional trials with minimal supervision, ensuring adherence to study protocol timelines, and working closely with the Principal Investigator to ensure participant safety. The Senior Clinical Research Assistant provides leadership and training to junior staff through in-person instruction, shadowing, and the development and maintenance of written materials. They are responsible for independently preparing and submitting regulatory packages to the Institutional Review Board (IRB) and assisting the Clinical Trials Manager with clinical trial start-up requirements and invoicing. The position requires frequent collaboration with internal and external vendors and departments to arrange services necessary for the conduct of 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 experience, 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, and/or annual review).
Clinical skills, such as phlebotomy, specimen processing, ECG, and 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 Epic medical record system.
Familiarity with the procedures of the OHSU Institutional Review Board.
Experience working with a senior population.
Completed CITI (Collaborative Institutional Training Initiative) courses – Good Clinical Practice, Human Subjects Research, and Responsible Conduct of Research.
SOCRA CCRP certification (Society of Clinical Research Associates Certified Clinical Research Professional).

Responsibilities

Recruit research volunteers by determining interest and eligibility in accordance with study protocol.
Explain complex study design and procedures in lay language to potential participants.
Create recruitment materials.
Screen and enroll eligible participants, and retain participants for the duration of the study protocol.
Attend and participate in community outreach events.
Coordinate scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services with minimal oversight.
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, and skin punch biopsies.
Maintain 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.
Prepare for and coordinate monitoring visits by CRO and federal agency representatives.
Maintain ongoing regulatory compliance and organization of all study documents and materials, adhering to Good Clinical Practice guidelines.
Independently prepare and submit regulatory packages to local and central IRBs, including initial submissions, modifications, annual reviews, protocol deviations, and adverse event reports.
Assist 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.
Complete all required case report forms timely and accurately during study visits.
Enter data into electronic data capture systems within sponsor-required timelines.
Resolve data queries issued by sponsor and/or study monitor timely.
Assist Clinical Trials Manager with tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures.
Assist in preparation of invoices.
In collaboration with the Clinical Trials Manager, lead and train junior staff through in-person instruction and shadowing, and develop and maintain written training materials.
Monitor changes to university and industry standards for clinical trials compliance and share new information with the clinical trials team.
Serve as trained, back-up study coordinator for several trials within the Movement Disorders Division, and other tasks as assigned.
Prepare for and participate in weekly meetings with the Clinical Trials Manager, including clinical research coordinator team and 1-on-1 meetings.