TI Sr Clinical Research Associate

Department Overview

The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug, infusion, and gene therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions.

The position is on point for all regulatory work, organizing and leading monitoring visits with sponsors, preparation and execution of activities needed during an FDA audit, and working with leadership on projects relating to study start-up. They also serve as a mentor to junior research staff in the group, is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group, as well as developing standardized workflows and SOP's for the program. Lastly, this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development.

The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.

Function / Duties of Position

The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following :

IRB Protocol Management and Development

• In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review.
• Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated
• Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed.
• Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols.

Study Documentation

Audit Support / Preparation

Monitoring Visits

Required Qualifications

Preferred Qualifications

Additional Details

Location : Marquam Hill & South Waterfront Campus

Schedule : Monday Friday, 6am 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines / goals. As salaried employee senior coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another.

Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification.

Due to the increased focused writing and focused attention on creation of sensitive study start-up regulatory materials this position is permitted to work remotely 1 day per week to complete this portion of the role.

The other aspects of this role are patient facing on-site role. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times this severely restricting the ability to conduct work remotely.

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All are welcomeOregon 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 Affi? 503-494-5148 or aaeo@.

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