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Function/Duties of Position
The Knight Cardiovascular Institute Senior Clinical Research Coordinator is responsible for various duties supporting clinical trials focused on the investigation of new device and drug therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, structural disfunction, and others encompassing an array of heart failure disease phenotypes. 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 senior research coordinator 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 the Program Manager and Clinical Trials Administrator on projects relating to study start-up. The senior coordinator also serves as a mentor to junior research staff in the group, is on point for collaborating with the program manager 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 Senior Research Coordinator is also 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 Structural Heart 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.
Required Qualifications
* Master's Degree or Bachelor's Degree
* 3 years of clinical research coordination experience with Master's Degree OR
* 5 years of clinical research experience with a Bachelor's Degree
* Very Strong understanding of Research Regulations and best practices.
* Strong knowledge of FDA regulations and audit preparation practices.
* Strong data abstraction and project management skills.
* Ability to prioritize multiple tasks at one time.
* Strong teaching skills with the ability to mentor junior staff.
* Must have excellent communication, analytical and organizational skills: both written and verbal.
* Ability to work independently and as part of a team while being collaborative in resolving problems.
* Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).
* Must have demonstrated excellent customer service skills both on the phone and in person.
* Demonstrated ability to work with a variety of diverse individuals and personalities.
* Must possess energy and drive to coordinate multiple projects simultaneously.
* Ability to use tact and diplomacy to maintain effective working relationships.
Preferred Qualifications
* Master's Degree
* Greater than 5 years of experience coordinating clinical trials.
* Preferred experience in coordinating trials in Cardiovascular Medicine.
* Experience managing regulatory activities for clinical trials.
* Previous experience at the Research Associate or Senior Coordinator level preferred.
* Prior experience leading clinical research teams and mentoring junior staff.
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 aaeo@ohsu.edu.
Full Time
$80k-102k (estimate)
05/01/2024
05/14/2024
ohsu.com
Portland, OR
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