TI Senior Clinical Research Assistant

Department Overview:

The Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM) provides expert care for patients with lung diseases in our pulmonary clinics, allergic and immunologic disorders and diseases in our allergy clinics, and critically ill patients in our intensive care units. In addition to our commitment to outstanding clinical care, we are proud of our extensive research programs, from basic science to clinical trials. Our educational mission includes teaching on many levels, including our two fellowship programs in Pulmonary, Allergy, and Critical Care and Critical Care Medicine.

Read more about the division: http://www.ohsu.edu/pccm

Read more about the team: www.prismtrials.com

The TI Senior Clinical Research Assistant is a highly organized and motivated clinical research coordinator who assists with multiple ongoing therapeutic/interventional (TI) clinical trials related to Pulmonary, Allergy and Critical Care Medicine. The coordinator will perform study procedures per the research study protocols and regulatory requirements, including participant recruitment, data and specimen collection, organization of study records, and study invoicing. The coordinator will work with clinical, research, and pharmacy units at OHSU as well as with external organizations such as sponsors, clinical research organizations, and regulatory bodies. Additionally, the coordinator will supervise and train student workers and volunteers. Other duties may include contract administration and invoicing, protocol administration, report preparation and editing, and regulatory responsibilities. Strong interpersonal and critical thinking skills for independent problem solving are needed to achieve scientific and administrative objectives.

This position is 100% in-person; duties will be performed on-site in OHUS clinics, inpatient wards, emergency room or outside student centers or locations. Weekend work (either Saturday or Sunday, depending on shift schedule) is an integral part of this position.

Function/Duties of Position:

• Clinical Trial Coordination: Screen, recruit, and consent patients for clinical trials in either ambulatory or inpatient settings (including the intensive care unit and emergency department). Assist with study interventions and assessments, research subject visits, and data collection, including biologic samples. Collaborates with various OHSU departments to operationalize research protocol. Coordinate activities with clinical units, Research Pharmacy, OCTRI, and other areas as needed. Develop case report forms as needed. Perform electronic data entry and trial audits. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed. Assist with site initiation and monitoring visits. Ensure compliance with all protocol and regulatory requirements, and help prepare required submissions and reports. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval. Assist with training research staff in study protocols. Assist with data queries as needed. Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
• Protocol Administration: Assist with development of research protocols, IRB proposals, case report forms, and administrative requirements as necessary.
• Student worker and Volunteer Supervision: Supervise student workers and volunteers, including recruitment, onboarding, scheduling, training and coaching volunteers and complying with division and institutional standards for managing volunteer programs. Supervise and audit work done by volunteers. Maintain volunteer records and conduct semi-annual evaluations for volunteers.
• Contract administration & invoicing. Responsible for clinical trial and/or industry study contract set up. Coordinate contract and invoicing processes as needed, assist with study set-up paperwork, and perform divisional review. Facilitate speedy processing of contracts and invoices. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval.
• IRB, IACUC and IBC regulatory liaison. Assist and monitor PI and research staff compliance with institutional and state and federal regulations. Submit protocols, amendments, and continuing review documentation for IRB review. Ensure that studies are updated, and protocols kept compliant. Provide resources to PI and staff for all aspects of protocol creation and maintenance w/ IRB, IACUC and IBC. Ensure compliance with ClinicalTrials.gov reporting.
• Other responsibilities. Other duties as assigned.

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

• Strong organizational skills and attention to detail.



• Demonstrated ability to take initiative and complete projects independently.
• Excellent communication, both written and verbal with fluency in English. Strong computer skills and advanced MS Office skills.
• Experience with database management.
• Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review.
• Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols.
• Understanding of best practices for clinical research.
• Project management skills

Preferred Qualifications:

• Working knowledge of FDA IDE/IND submission process, eCRIS, eIRB, and experience with REDCap.
• Familiarity with electronic medical records (preferably EPIC), chart review and medical terminology.
• BLS certification

Additional Details:

Hours will be 12:00pm to 8:30pm, scheduled for one of the following shifts:

• Sun – Tue
• Sun – Wed
• Tue – Sat
• Wed - Sat

Ability to carry and lift up to 25 pounds. Ability to walk/travel to all the division’s offices spaces and clinical sites. Ability to drive for travel on occasion, as needed. Ability to stand or sit for up to 8 hours per day. Ability to work on-site.

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 askhr@ohsu.edu