TI Sr Clinical Research Assistant

Oregon Health & Science University; Portland (OR); On-site; USD 65,000 - 90,000; Full time

Job summary

Oregon Health & Science University in Portland, OR, seeks a Therapeutic Intervention Senior Clinical Research Assistant in the Epilepsy Division, Department of Neurology to coordinate complex interventional trials with minimal supervision and ensure participant safety.

The role involves preparing and submitting regulatory packages to IRBs, assisting with trial start-up, data entry, and invoicing while collaborating with sponsors, CROs, and internal departments.

Qualifications

• 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.
• 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

Responsibilities

• 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. May also include attendance at and participation in community outreach events.
• Study Coordination: with minimal oversight, 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. Effective and professional communication with study team, sponsors, CROs, investigators, IRBs, and other departments at OHSU. Preparation for and coordination of monitoring visits by CRO and federal agency representatives.
• Regulatory documents & submissions: 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. Assist Clinical Trials Manager with clinical trial start-up, including 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.
• 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.
• Invoicing & Expenses: assist Clinical Trials Manager with tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures; may also assist in preparation of invoices.

Education

Bachelor’s Degree in relevant field AND 1 year of relevant experience

Associate’s AND 3 years of relevant experience

4 years of relevant experience

Equivalent combination of training and experience

Job description

Department Overview

Therapeutic Intervention Senior Clinical Research Assistant position in the Epilepsy Division, Department of Neurology. Responsible for coordinating multiple complex therapeutic interventional trials, with minimal supervision, while adhering to study protocol timelines and working closely with the Principal Investigator to ensure participant safety. Independently prepares and submits regulatory packages to the IRB and assists Clinical Trials Manager with clinical trial start-up requirements and invoicing. Frequently collaborates with internal and external vendors and departments to arrange services required in the conduct of clinical trials.

Please include a cover letter with your application and resume.

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. May also include attendance at and participation in community outreach events.

Study Coordination: with minimal oversight, 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. 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 documents & submissions: 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. 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.

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.

Invoicing & Expenses: assist Clinical Trials Manager with tracking and reviewing study billing, including review of hospital charges and tracking invoiceable assessments and procedures. May also assist in preparation of invoices.

Required Qualifications

• 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

Preferred Qualifications

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

Additional Details

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. Ability to stand and walk throughout the OHSU campus for long periods of time during study visits.

Why apply to OHSU?

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 [e-mail]