Senior Clinical Research Assistant

Department Overview

The Dotter Department of Interventional Radiology serves as a beacon of both internationally recognized research and locally delivered advanced clinical care. The Dotter Department of Interventional Radiology is a part of the OHSU School of Medicine, with its own admitting service and clinic. We provide all the diagnostic angiographic, interventional radiologic, and neurointerventional services to the OHSU and VA Hospitals.

 

This position is under the supervision of the Clinical Research Manager in the Dotter Department of Interventional Radiology. This position's duties support the mission goals and objectives of OHSU and the School of Medicine. Specifically, the Research Coordinator is responsible for the management/compliance/conduct of research projects assigned which are funded within the Department. Primary duties include patient study enrollment, counseling, and education of patients/families regarding study participation and compliance including treatment plan, abstraction/coordination/collection of protocol required elements (data, specimens etc) for related clinical trials. This individual may be responsible for maintaining registries which are ongoing observational databases for specific medical conditions that track not only disease progression but patient outcomes and general disease trends.

Function/Duties of Position

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.

Function Independently

• Act independently to achieve desired results; regularly accept accountability for outcomes within the appropriate sphere of responsibility, and willingly perform other essential tasks 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.
• 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

Preferred Qualifications

• Bachelor's degree with major courses in the field of research (biological or health care sciences).
• 2-3 years experience as a research coordinator.

Additional Details

Monday through Friday, commonly 7:00am – 3:30pm or 8:30am – 5:00pm with possible weekend call coverage. Hours may be flexed to meet the demands of the clinical trials. May be required to work evenings or weekends to cover patient visits or call. International or domestic travel is possible. The appointee will be in contact with human tissues & fluids and will be responsible for fluid and tissue collection as related to study protocol. Training will be provided for proper handling, processes, and procedures.

All are welcome

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 [email protected].