TI Senior Clinical Research AssistantTI Clinical Research Assistant 2
TI Senior Clinical Research AssistantTI Clinical Research Assistant 2
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Job Description
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.
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Read more about the team:
The TI Senior Clinical Research Assistant/ TI Clinical Research Assistant 2 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.
Function/Duties of Position
Duties will be performed onsite in OHSU clinics inpatient wards emergency room or outside study centers or locations.
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 semiannual 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 setup 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 reporting.
Other responsibilities: Other duties as assigned.
Our clinical interests include all areas of lung disease allergy and critical illness so the position requires you to work with patients who have COVID19 or other infectious disease.
Required Qualifications
Bachelors Degree 4 yr) in relevant field AND 1 year of relevant experience OR
Associates 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 indepth 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
All are welcome
Required Experience:
Senior IC
Employment Type
Full-Time
