The mission of the Knight Clinical Research Management organization is 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. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population.
This position is responsible overseeing all regulatory components of oncology clinical research studies in support of the mission of the Knight Cancer Institute. The position has ownership of the oncology study start-up process, including the tracking of 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 addition, the position also has oversight over the feasibility assessment, essential regulatory document completion, beacon build, eCRIS, and budget and contract negotiation processes. The position also has ownership of all regulatory tasks that must be completed over the lifetime of the oncology clinical research studies they support, including the processing of protocol amendments, investigator brochures and safety reports, consent form updates, and applications for continuing approvals.
The successful candidate will have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research. Strong 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 general supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements; above average time management skills.
Bachelors degree and at least four years of relevant experience (at least two years in clinical trials/research)
Key competencies required:
Ability to prioritize multiple tasks at one time
Must have excellent communication, analytical and organizational skills: both written and verbal.
Ability to work independently and as part of a team while being collaborative in resolving problems.
Must be proficient with computers running Windows and PC applications, e.g., MS Excel, Oracle, Access, Word, and PowerPoint). Typing 60wpm
Must have demonstrated excellent customer service skills both on the phone and in person.
Must possess energy and drive to coordinate multiple projects simultaneously.
Ability to use tact and diplomacy to maintain effective working relationships
Bachelor's or Masters degree with coursework in science Project management training or experience 1 year regulatory experience Experience using project management software (eg, MS Project)
If you do not meet the minimum qualifications for this Regulatory Project Manager position, consider applying for one of our Novice or Practitioner level CRC positions in Knight Clinical Research Management here:
Note to internal OHSU applicants: to apply to the above-mentioned posting, you must access it from the internal OHSU job portal and search by Req# 2019-1596.
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 [email protected]
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