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 heads up the Coordinating Center Team for the groups FDA-R01 funded Phase 2 multi-site clinical trial (NTM-Clofazimine). Responsibilities also include independently interacting with external research regulatory bodies, preparing reporting documents, and overseeing the quality of work at sub-sites. In addition, this position includes supporting the Winthrop Research Groups incoming clinical trials, both industry-sponsored and federally funded. Duties include interfacing with sponsors, determining study feasibility, reviewing and negotiating budgets, managing regulatory submissions and essential documentation, and working with the Clinical Research Project Manager to determine appropriate staffing for clinical trials and research protocols.

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

1. Project Manager for an FDA-R01 funded Phase 2 multi-site clinical trial (NTM-Clofazimine). Responsibilities include budget management, oversight of enrollment, protocol execution and data management across sub-sites, assisting with sub-award execution, ensuring execution of award milestones and deliverables, maintaining project ClinicalTrials.gov record, executing federal and institutional reporting requirements including IND submissions and quarterly progress updates to funding sources. This position works closely with the study team to provide oversight for study performance at sub-sites, leading stakeholder calls and in-person meetings

2. Support incoming clinical trials and research protocols through the start-up process, including budget development and negotiations, protocol review and feasibility determination, IRB development and submission, development and collection of essential documentation. Incorporate OHSU HR policies within the operations of the group by developing and executing onboarding and training SOPs.

3. Project Manager 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.

4. Grant and manuscript writing support as required: Assist investigators in grant writing preparation, budget development, and submissions. Review/edit manuscripts to ensure submission-required details are addressed

• Masters degree with major courses in relevant field and 3 year of experience in clinical research, research administration, or research project management; OR Bachelors degree with major courses in field of research and 5 years of relevant experience.

• Excellent interpersonal, organizational, and comminication skills.

• Meticulous record keeping and organization skills.

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

• 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.

• Masters Degree in Administration, Education, or Public Health.
• 2-7 years of experience in clinical research or clinical administration and 2-4 years of project managements.

• 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.

• Good Clinical Practice certification

Working conditions:
Monday-Friday; between 8:00 AM - 4:30PM (flexible and will vary depending on study needs).

Physical demands & equipment usage:

Prolonged standing. Prolonged screen-time. Lifting 25+ pounds.

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