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 groups 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 teams participation in the several multi-site clinical trials and is the Project Director of the Coordinating Center Team for the groups 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 and grants, and providing mentorship and support to junior staff.

In addition, this position includes running the OHSU-PSU SPHs Oregon Mycobacterial and Chronic Chest Infection Fellowship Program and coordinating the groups annual NTM Research Consortium Meeting.

Please do not contact Dr. Winthrop. All position inquiries can be sent directly to Sarah Siegel, PhD, MPH at siegels@ohsu.edu.

1. Project Director 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, central IRB submissions, identifying fiscal points of contact and managing subaward agreements and disbursements to consultants, supporting sub-site set-up logistics, data management across 26+ sites, ClincialTrials.gov record, 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. Provide indirect supervisory support for Coordinating Center study staff.
2. 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.
3. Administrator for the Oregon Mycobacterial and Chronic Chest Infection (OMCCI) Fellowship Program. Develop and execute standard operating OMCCI Program procedures. Demonstrate working knowledge of institutional and federal international affairs policies to provide applicable Fellows with Visa, Medical Licensing and Credentialing support. Assume responsibility for Program executions, demonstrating creativity and problem solving ability to accommodate and support Fellows unique needs.
4. Coordinate the annual NTM Research Consortium Meeting, including oversee the preparation, identification of Sponsors, financial aspects, and day-of activities.

• Doctorate degree in relevant field OR Master's degree in relevant field and 5 years of relevant work experience; OR Bachelors degree with major courses in field of research and 9 years of relevant experience.

• Excellent interpersonal, organizational, and comminication 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.

• Experience with EndNote or other citation software.

• 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.

• 6-10 years of experience in clinical research, 2-5 years experience in managing research teams or labs.

• Basic understanding of statistical testing.

• Familiarity with medical language.

• Experience with group facilitation and public speaking.

• Some design of initiatives and procedures to achieve program objectives and in-reach throughout institution.

• Interest and/or experience preparing presentations and media to share results and efforts publicly.

• Experience on clinical trials from start-up to close-out.

• Good Clinical Practice (GCP) Certification

Physical demands & equipment usage:

Prolonged standing. Lifting 25+ pounds.

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