Clinical Research Assistant

Oregon Health & Science University•Portland, OR

2d•Hybrid

About The Position

This position functions primarily as a Clinical Research Assistant supporting multiple observational, registry-based, and interventional clinical research studies within the Department of Emergency Medicine. Working closely with Principal Investigators, Research Managers, Study Coordinators, and study teams, the individual will assist with study startup, regulatory activities, participant screening and enrollment, informed consent activities, data collection and abstraction, data quality monitoring, study documentation, and study closeout activities. This person will need to be willing to conduct blood draws on subjects. Some study-related duties may involve on-call time and travel within the Portland Metro Area. The position will coordinate research operations across multiple studies and support regulatory- compliant conduct of human subjects’ research. Responsibilities include working with electronic medical records, research databases, research participants, clinical partners, and external study collaborators while ensuring adherence to study protocols, Good Clinical Practice (GCP), HIPAA requirements, and institutional policies. As part of professional development and workforce succession planning, this position will receive structured training in research regulatory coordination activities over time. Regulatory responsibilities will initially represent a small portion of the role and will be performed under the guidance of experienced regulatory personnel. Training will include exposure to eIRB, OnCore, protocol amendments, continuing reviews, study startup documentation, and regulatory record maintenance. As competency develops and departmental needs evolve, regulatory responsibilities may increase. Due to the nature of emergency medicine research, this position must participate in shared after-hours and weekend study coverage to support participant enrollment and study operations when required. The ability to have a flexible schedule, day-to-day and week-to-week, is required. This person must be able to arrive at OHSU and local Portland-area hospitals within 1 hour of any study activation.

Requirements

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
Experience working on research studies in an emergency department.
Work experience on at least 1 EFIC- regulated clinical trial.
Experience obtaining informed consent from research participants.
Experience working through at least 1 clinical trials’ full study lifecycle, from start-up to closeout, assisting in operations such as maintaining study compliance, operational efficiency, and successful study execution.
Data collection; including the use of local and web-based databases, longitudinal data tracking, and data confidentiality rules.
Proficient in MS, Word, Excel, and Access.
Prior experience with any Electronic Medical Record (EMR) System.
Ability to work with very detailed information and independent decision-making and problem-solving skills required.
Requires exceptional attention to detail.
Ability to multi-task and prioritize tasks/duties under pressure; outstanding interpersonal skills to interact professionally with faculty, staff, and all levels of management.
Excellent communication skills and organizational skills.
Ability to independently manage their daily schedule and adapt to a changing work plan.
Able to work independently without much supervision.
Ability to respond, as needed/assigned, after hours for study call shifts on nights and weekends.
Must be willing to perform blood draws (phlebotomy) for studies.
Ability to perform the job duties with or without accommodation.

Nice To Haves

Major courses in the field of research are preferred.
Minimum 1-year experience working on research studies in an emergency department.
Experience with data abstraction for research purposes.
Experience supporting research regulatory submissions or maintaining regulatory study documentation.
Familiarity with OHSU eIRB and eCRIS systems.
Experience with study startup and closeout activities.
Database development and management.
Spanish language fluency
Familiarity with EPIC medical record system.
Competency with RedCap.
Prior training in Human Subject Research, Responsible Conduct in Research and Good Clinical Practice
Ability to learn and apply federal, state, sponsor, and institutional regulations governing human subjects research.
Strong document-management, organization, and records-retention skills.
Ability to maintain accurate regulatory files and audit-ready documentation.
SOCRA or ACRP Certification
Phlebotomy Certified

Responsibilities

Coordinate studies. This can involve startup work, regulatory activities, study management throughout the study, screening, consenting and enrolling patients, managing data flow, coordinating documentation and data storage, coordinating prehospital and hospital data flow, reviewing timeliness and prioritization needs with the study team to facilitate adherence to study-related benchmarks.
Review medical records, abstracting relevant variables into electronic systems.
Complete enrollment forms for both registry and trial patients. Also includes Pre-Hospital and Hospital data abstraction as needed, entry, and tracking using the local and web-based study databases.
Ensure adherence to research protocol and quality of data collection.
Review current protocols and policies.
Interact with outside providers at local hospitals with ongoing study awareness, followed up by patient-level communication for consenting.
Coordinate communication and meetings with external partners
Assist with assembling documentation for site progress report with PI & study team
Assist Regulatory Coordinator with IRB and eCRIS submissions, protocol modifications; progressive training to take on additional regulatory coordinator responsibilities.
Cover rotating after-hours call shifts for studies where 24/7 enrollment is required.