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.
Function/Duties of Position
We are seeking a full-time or part-time Sr. Regulatory Project Manager (OHSU classification: Research Project Manager).
At the Knight Cancer Institute, we strive to have research opportunities for every patient that is interested; this means that projects must move forward in spite of any transitions, staffing gaps, or other workforce challenges. In order to best serve our patients, we are seeking to create a pool of expert Regulatory Professionals that will 'float' across cancer types to fill gaps and keep high priority projects moving forward. One example of this is the Single Patient IND: when a patient may benefit from an investigational drug which cannot be accessed through any other mechanism. A SP-IND requires a drafted consent form, IRB review, and collaboration with the sponsor, clinician, and our FDA Support Team to be completed in a matter of days so that the patient may receive the drug when they need it. The members of the float pool will be deployed where the need is greatest and perform regulatory components of clinical research studies, whether long term clinical trials or SP-INDs, in support of the mission of the Knight Cancer Institute. The position will work with different programs within the Knight Clinical Research Management organization. They will provide relief, backup, or interim support in order to maintain progress on critical projects.
The position will assist or lead 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, and internal and external flowsheet updates. In addition, the position may assist with or lead feasibility assessment, essential regulatory document completion, beacon build, eCRIS, and budget and contract negotiation processes. The position may be asked to perform any 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 limited supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with excellent understanding and communication of study protocol requirements; strong time management.
Education and experience:
Master's in relevant field AND 3 years of relevant experience OREquivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.Three years clinical trials/research experience
Job Related Knowledge, Skills and Abilities (Competencies):
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.
High level of organization, attention to detail, troubleshooting, and prioritizing skills
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
1-3 years regulatory experience
Project management experience or certification
Experience using project management software (eg, MS Project).
Please submit a resume and cover letter with your application.
As of Oct. 18, 2021, 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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