The postdoctoral fellow will function as a research fellow in the Knight Cardiovascular Institute. The main project they will be working on is understanding tricuspid valve interventions and imaging. They will work on analyzing CT imaging of the tricuspid valve, compare it with Echo, and collect perioperative data for patients undergoing tricuspid valve evaluation including intracardiac Echo. The postdoc fellow at the end of this fellowship will have a deep understanding of the tricuspid valve functionality, multimodality imaging (CT, Echo, ICE, etc.) and various interventions. The fellow will work closely with interventional cardiologists, cardiac surgeons, and echocardiographers on these projects including, IRB submission, data collection, analysis, and manuscript writing.

Study Protocol Management and Development-

• In collaboration with the principle investigator and based on sponsor protocol, develop/submit new IRB protocols for review as well as submit required maintenance amendments to the protocol as needed.
• Work in collaboration with coordinator teams and Clinical Research Managers to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments are submitted timely when adjustments are needed.

Study Documentation-

• Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines. 
  • Oversight and maintenance of all regulatory binders for each study
  • Ensuring proper filing of all study correspondence between study team and sponsor for audit purposes
  • Ensure proper filing of all correspondence between IRB and study team for audit purposes
  • Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes
  • Ensure centralized documentation of all monitor visit reports if applicable.  This includes site selection, site initiation, monitoring visits, and close-out reports
• Work with study teams to ensure all Serious Adverse Events for patients enrolled in studies being supported are reported to the sponsor and any related regulatory authorities.
• Work with study teams to ensure all screening, subject identification, and enrollment logs are filled out in accordance with regulatory requirements

Study Conductance-

• Work with Primary Investigator to collect and analyze study data.  This may involve the following:
• Work with the PI in screening and consent of patients into studies
• Collect data regarding subject visits/procedures relevant to the study
• Navigate EMR and update relevant documentation based on treatments/correspondence patients enrolled in the study have received 40 Yes

Data Analysis-

• Upon completion of the study use biostatistical assessments to identify potentially significant outcomes. 

Data Publication-

• Assist PI in developing publications that outline outcomes identified at the end of the study.

Education:

• Doctoral degree in a biological or biomedical science required

Experience:

• Experience in clinical research or clinical services
• Experience in biostatistics/analyzing clinical data

Job Related Knowledge, Skills and Abilities (Competencies):

• Strong understanding of clinical research regulations and best 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).
• 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

Education:

• Doctoral degree in a biological or biomedical science required

Experience:

• Extensive experience in clinical research and/or clinical services
• Extensive experience in biostatistics/analyzing clinical data

Job Related Knowledge, Skills and Abilities (Competencies):

• Knowledge of FDA regulations and audit preparation practices

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.