Senior Clinical Research Associate

Department Overview

The OHSU-PSU School of Public Health (SPH) is aligned with the American Public Health Association in declaring racism a public health crisis, and our School is committed to becoming an antiracist SPH. We are working to center social justice in our internal and external work as a school and are committed to addressing structural and institutional racism, and to holding ourselves accountable to this work.

The Infectious Disease Research Group is based out of the OHSU-PSU School of Public Health specializes in evaluations of infectious disease, in individual patients and the population as a whole. The group’s experts are national leaders in two rare diseases that predominantly affect the lungs – nontuberculous mycobacterial, or NTM disease, and bronchiectasis. In addition to NTM disease and bronchiectasis, other areas of research include rheumatologic disease, drug safety and pharmacoepidemiology, and vaccines.

Function/Duties of Position

This senior clinical research associate position is responsible for independently leading several of the team’s immunological and vaccination clinical research programs, including investigator-initiated research studies, as well as other infectious disease observational or NTM and bronchiectasis epidemiological studies. This position is also be responsible for helping to develop a new biobank, focusing on the creation of standard operating procedures, safety manuals, and categorization systems to manage human samples. A successful applicant will have experience managing various databases, developing appropriate reports, and providing statistical analysis. Evidence of successful publications, either posters or manuscripts, is necessary. This position is also responsible for the application of scientific data into a cohesive format for protocol development to further the grant application process. As part of this role, this individual will interface across multiple departments and divisions across OHSU, as well as external collaborators such as other academic institutions.

Responsibilities Include

• Independently manage relationships with external research regulatory bodies and external funders.
• Oversee research programs, including external subsite management.
• Contribute scientific expertise and data analyses to the development of grant applications or publications, as well as being willing to represent the team at national conferences to present these data.
• Able to independently seek out appropriate funding opportunities and co-author submissions.
• Prescreening clinic to determine patient eligibility for all ongoing studies within the IDRG.
• Review project-specific reports developed by junior staff, provide appropriate feedback to improve junior staff’s work output, and then present report to Principal Investigators and other collaborators.
• Ensure data quality through monitoring and audits, as well as regulatory compliance for local and central IRBs, and Investigator-held INDs through the FDA.
• Administer research program funding in line with proposed budgets, develop necessary financial reports for managerial review.
• The individual in this role will have excellent person-skills, be detail-oriented, and able to track multiple projects long-term. In addition, this individual must have leadership skills and several years’ worth of experience mentoring junior staff or students. This position requires majority on-site work, with potential opportunity to work remotely.
  
  

Required Qualifications

• Master’s degree in relevant field and 5 year of clinical research coordination experience; OR Bachelor’s degree in field of research and 9 years of clinical coordination experience.
• Ability to prioritize work demands, and coordinate research protocols with other staff.
• Ability to communicate effectively, in both written and oral formats.
• Meticulous record keeping and organization skills.
• Work independently, take initiative, manage deadlines.
• Skilled in writing clear and concise reports for internal and external audiences.
• Demonstrated independence and competence to perform data management and protocol oversight.
• Working knowledge of Regulatory, FDA, DHHS, and other agency guidelines that govern clinical research.
• SoCRA or ACRP required within 12 months of hire.
  
  

Preferred Qualifications

• PhD degree in Microbiology, Immunology, or Epidemiology.
• 5+ years of relevant clinical research experience.
• 3+ years of relevant laboratory experience.
• Familiarity with medical language.
• Experience with group facilitation and public speaking.
• Interest and/or experience preparing presentations and media to share results and efforts publicly.
• Experience on clinical trials from start-up to close-out.
• Experience with EndNote or other citation software.
• Evidence of successive increases in teaching/mentoring responsibilities.
• Familiarity with biobanking protocols and safety manuals, blood processing, BSL2, BSL2+, or BSL3 proficiency.
• Good Clinical Practice (GCP)
  
  

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.