Job Description: Oregon Health & Science University
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.
Senior Clinical Research Assistant
US-OR-Portland
Job ID: 2024-32649 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Marquam Hill)
Overview
Clinical Trials Management.
Responsible for assigned protocols administered through the Department.
Trial management duties include Site selection materials and processes, maintenance, and submission of patient data, analysis and evaluation of protocol activities, maintenance and preparation for quality assurance audits, and all other pre/post-award activities associated with the project not specifically assigned.
Act as liaison between the PI, External Research Sponsor, Clinical Research Organization, and Medical Monitors with external research
Also includes all data collection, entry, and management on assigned studies.
Patient Contact.
Responsible for patient assessment for protocol eligibility, consenting, counseling of patients regarding study schemas; study calendar, treatment plan, patient education, and coordinating follow-up care.
Record all clinical information into appropriate research documents from subject or source documents, including medical history and other evaluations pertinent to the study, and maintain accurate records.
Perform participant interviews and physical measurements.
Assist in the collection of specimens.
Clinical Registry Management.
Ensure registry compliance with Funder, Federal, State, local, and OHSU requirements.
Enter complete and accurate data entry in the registry from source documents, maintain organized source binders, and obtain source documentation for registry input promptly.
Recruit and enroll new qualifying registry participants.
Demonstrate effective communication with faculty and staff as required to organize patient appointments, complete informed consent, and administer questionnaires.
Regulatory Compliance &Administrative.
Maintenance and submission of patient data, analysis and evaluation of protocol activities, maintenance, and preparation for quality assurance audits.
All data management on assigned studies.
Must be able to do data entry for extended periods.
Primary contact for the study assigned by the Clinical Research Manager.
Work with Clinical Research Manager to ensure the timely submission of protocols to funding agencies.
Assist with the development of investigator-initiated trials with minimal supervision.
Assist with the training of junior staff and temporary personnel.
Responsibilities
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
Intermediate and experienced knowledge of Word, Excel, and other MS Office programs. Demonstrated high level of organization and ability to efficiently manage multiple tasks. The ability to speak and communicate clearly and demonstrate a high level of customer service to other members of the health care team both at OHSU and outside entities. Previous work with physicians in an academic environment. Familiarity with the clinical trial regulatory process
Qualifications
Bachelor's degree with major courses in the field of research (biological or health care sciences)
