The Department of Emergency Medicine at OHSU is home to over 150 faculty and adjunct faculty under the direction of Mary Tanski, M.D., M.B.A., associate professor and Department Chair. Our clinician's staff at OHSU's Level 1 Trauma Center and Doernbecher Pediatric ED as well as our three community Emergency Departments (Hillsboro Medical Center, Adventist Health Portland, and Columbia Memorial Hospital), three ED Observation Units, the Immediate Care Virtual Visits Program, and the Oregon Poison Center. The Department of Emergency Medicine at OHSU has always been highly ranked in NIH Funded Research and is home to the Center for Policy and Research in Emergency Medicine (CPR-EM). Our residency program currently trains 33 residents and offers a diverse training environment through partnerships at several area hospitals. OHSU offers EM specialty training in the form of select fellowships in: Research, Education, Pediatric Emergency Medicine, Administration, EMS, Toxicology, and Ultrasound. We are proud to serve OHSU's mission of Healing, Teaching, and Discovery. 

 

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.

• 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.
• Protocol compliance, QA/QC, study documentation - Ensure adherence to research protocol and quality of data collection. Review current protocols and policies.
• Participant, provider, and stakeholder communication -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
• Clinical study project coordination and study team support - Assist with assembling documentation for site progress report with PI & study team  
• Regulatory training and support activities (eIRB, OnCore, amendments, continuing reviews, regulatory files) - 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. 

• 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.

• 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

Work schedule: Mon-Fri, generally during business hours (8am-6pm), start and stop times can be variable depending on work unit and study project needs. Generally, this position requires 4 days in office and can have an option for one remote workday per week. Hybrid schedules may be changed based on operational need.

Standard office setting; Daily use of computers and phones, mobile devices & study related equipment. Must be able to sit and perform repetitive computer tasks for at least 2 hours at a time. Time may be spent in the busy Emergency Department setting during clinical trial enrollments. Must be able to stand for 1-2 hours at a time during study enrollment.

Primary Work location: Marquam hill campus and telework will be primary locations. Travel to EDs, and pre-hospital agencies in the Portland-Metro area may be needed.

Occasional call shifts/ after-hours work required for study enrollment (nights/weekends, generally no more than 5-7 times/month).

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 askhr@ohsu.edu