Oregon Health Science University
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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SunIRef:cr006 Department Overview: The Winthrop Research Group is based out of the OHSU-PSU School of Public Health under the direction of Kevin Winthrop, MD, MPH. The group 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. This position focuses on managing the team’s participation in the several multi-site clinical trials and is the Project Manager of the Coordinating Center Team for the group’s PCORI-funded multi-site pragmatic trial (MAC 2v3). Responsibilities also include independently interacting with external research regulatory bodies, preparing reporting documents, overseeing the quality of work at sub-sites, managing contracts, grants, and budgets. This position includes providing support for both the OHSU-PSU SPH’s Oregon Mycobacterial and Chronic Chest Infection Fellowship and the Casey Eye International Ophthalmology Fellowship Programs. In addition, this position supports the coordination of the group’s annual NTM Research Consortium Meeting. Please do not contact Dr. Winthrop. All position inquiries can be sent directly to Sarah Siegel, PhD, MPH at . Function/Duties of Position: Project Manager for the PCORI-funded multi-site pragmatic trial (MAC 2v3) Coordinating Center, with tasks that include tracking and reporting to funders and stakeholders, tracking contracts, identifying fiscal points of contact and managing subaward agreements and disbursements to consultants, supporting sub-site set-up logistics, oversee IRB and other regulatory maintenance, primary contact for all PCORI-communications, prepare and submit all required PCORI reporting submissions, manage uploads and updates within the PCORI online portal, and coordinating all stakeholder meetings. Project Manager, or support, for additional clinical trials, including COVID-19 and NTM research, in the infectious disease space. Responsibilities include IRB submissions, developing budgets and supporting federal submissions, collecting and managing essential documentation, interfacing with industry sponsors and regulatory authorities, preparing IND submissions, SAE initial and follow-up reports, and other relevant documentation. Administrator for the Oregon Mycobacterial and Chronic Chest Infection (OMCCI) Fellowship and International Ophthalmology (IO) Fellowship Program. Demonstrate working knowledge of institutional and federal international affairs policies to provide applicable Fellows with Visa, Medical Licensing and Credentialing support. Coordinate the annual NTM Research Consortium Meeting, including oversee the preparation, identification of Sponsors, and day-of activities. Required Qualifications: Master’s degree with major courses in relevant field and 3 year of experience in clinical research, research administration, or research project management; OR Bachelor’s degree with major courses in field of research and 5 years of relevant experience. Excellent interpersonal, organizational, and communication skills. Meticulous record keeping and organization skills. Ability to work independently, take initiative, manage deadlines. Skilled in writing clear and concise reports for internal and external audiences. Familiarity with managing budgets. Working knowledge of IRB guidelines. Ability to utilize project management and database systems (i.e., REDCap, Qualtrics, etc.) to record, track and report. Working knowledge of FDA, DHHS, and other agency guidelines that govern clinical research. Computer skills in MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat DC. Preferred Qualifications: Master’s degree in public health or administration and 5 year of experience in clinical research, research administration, or research project management. 6 years of experience in clinical research or research administration and 2 years experience in project management. 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. Good Clinical Practice (GCP) Certification Additional Details: Physical demands & equipment usage: This position may include prolonged standing and lifting 25+ pounds. 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 or .