SMMART is the cutting edge, flagship program of the Knight Cancer Institute’s new Precision Oncology program. Our name stands for Serial Measurements of Molecular and Architectural Responses to Therapy, and we are designed to change the way we approach cancer research and treatments. SMMART has the ambitious goal of developing innovative cancer treatment regimens that last longer (are more durable) and allow better quality of life (are more tolerable) for patients with cancer at all stages. Through comprehensive and longitudinal analysis, the SMMART program evaluates each patient’s individual cancer tumor with the mission to understand why standard therapies often stop working, and to develop novel combinations that may stop cancers from becoming resistant to cancer drugs.
SMMART is a highly adaptive, fast-paced, intense research environment. We work to support the conduct of translational clinical research, aimed at improving the lives of people and families with cancer, by applying innovative strategies for cancer prevention, screening, diagnosis, and treatment that is uniquely tailored to each patient. We support this model through proactive, high quality, and efficient study management in compliance with federal regulations and local policies and procedures. We navigate the complex world of oncology and clinical studies, and work with a very vulnerable and sick population.
We are seeking a motivated Sr. Regulatory Project Manager (Research Project Manager) who is eager to learn and interested in joining our highly dynamic team whose goal is to change how we attack cancer.
The Sr. Regulatory Project Manager is responsible for carrying out all regulatory components of clinical research studies in support of the mission of the SMMART Clinical Trials program within Precision Oncology and Knight Cancer Institute.
The Sr. Regulatory Project Manager is responsible for carrying out the oncology study start-up process, including the tracking of oncology clinical trials start-up metrics, communicating with all start-up process owners and participants, consent form development, CRRC and IRB submissions and all communications/ responses, CTRP registration workflows, flowsheet updates, and VIA Oncology updates. In collaboration with the PI and study team, they will assist in the development of the protocol and protocol-related documents (e.g. informed consent forms, study tools, lab manuals, CRRC and IRB communications/responses, IND applications, essential regulatory documents, CTRP registration, eCRIS builds), and feasibility assessments.
The Sr. Regulatory Project Manager is also responsible for carrying out all regulatory tasks that must be completed over the lifetime of the oncology clinical research studies they support, including but not limited to the processing of protocol amendments, investigator brochures and safety reports, consent form updates, and applications for continuing approvals.
The Sr. Regulatory Project Manager will have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research. Excellent organizational, interpersonal and writing skills are required. Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time is necessary. Attention to detail, strong understanding of the scientific method, project management, customer service, and critical judgment skills are essential. Requires limited supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with excellent understanding and communication of study protocol requirements; excellent time management.
Education and experience:
Master's in relevant field AND 3 years of relevant experience
Equivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.
Relevant experience must include: three years clinical trials/research experience
Key competencies required:
Please submit a resume and cover letter.
Note: all OHSU employees are required to be fully vaccinated against COVID-19. Fully vaccinated means you have received both doses of a two-dose, or one dose of a single-dose, FDA- or WHO-authorized COVID-19 vaccine and at least 14 days have passed since your final dose of COVID-19 vaccine. If you apply for and are offered a position, you must be fully vaccinated prior to starting work.
If the position you are offered does not require direct, in-person patient care contact, you may request an exception to the vaccine policy for medical or religious reasons. OHSU uses very narrow criteria under the law to allow an exception and very few requests are being approved.
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