OHSU School of Dentistry · 2 months ago
TI Senior Clinical Research Assistant/TI Clinical Research Assistant 2
US-OR-Portland
Full-time
Onsite
Mid, Senior Level
$50K/yr - $75K/yr
1+ years expOHSU School of Dentistry is dedicated to providing expert care in pulmonary medicine and conducting extensive research programs. The TI Senior Clinical Research Assistant will coordinate clinical trials, assist with participant recruitment and data management, and ensure compliance with regulatory requirements while supervising student workers and volunteers.
Higher Education
Responsibilities
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
Assist with development of research protocols, IRB proposals, case report forms, and administrative requirements as necessary
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
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
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 duties as assigned
Qualification
Required
Bachelor's Degree (4 yr) 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
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
Company
OHSU School of Dentistry
The School of Dentistry shares the mission of the Oregon Health & Science University to provide educational programs, basic and clinical research, and high-quality care and community programs.
201-500 employees
H1B Sponsorship
OHSU School of Dentistry has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
Funding
Current Stage
Growth StageCompany data provided by crunchbase