Regulatory Coordinator Or Regulatory Project Manager (Sr. Research Assistant)

Department Overview: 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.
Every Knight Cancer employee is expected to embody our guiding principles:

• We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently.
• We SUPPORT each other—Respect leads to trust, which leads to excellence.
• We work as a CONNECTED team — We must leverage our collective brain power to conquer cancer because no one individual can do it alone.

Function/Duties of Position: We are hiring personnel at the Regulatory Coordinator (novice) level and Regulatory Project Manager (practitioner) level and in the following areas:

• Sarcoma clinical trials
• Silver Team. The silver team supports a diverse portfolio, ranging from oncology Phase 1 (first in human) solid tumor trials to Phase 2/3 melanoma clinical trials. Trials are complex and require cross-functional collaboration.

This position is responsible for overseeing regulatory components of clinical research studies in support of the mission of the Knight Cancer Institute. The position also has ownership of regulatory tasks that must be completed over the lifetime of the clinical research studies they support, including the processing of protocol amendments, investigator brochures, consent form updates, and applications for continuing approvals.
Key responsibilities include:
Study Start-Up Project ManagementManage the study start up activities from feasibility to study activation. This requires tracking the critical project milestones and ensuring that responsible parties are on track for their assigned start up tasks. This requires strong organizational, communication, and tracking skills, as well as the ability to think critically and problem solve various start up obstacles.
Active management of the study modification process.Evaluate study modifications and other changes to the conduct of the study to identify feasibility and all downstream impacts to systems in place to support study conduct and collaborate with responsible parties to ensure appropriate changes made to those systems (e.g., Beacon builds, Research Pharmacy deliverables, eCRIS study build, regulatory document collection, budget amendments, and training). Communicate applicable changes to responsible parties and ensure completion of responsibilities.
Direct responsibility for preparation of all documentation required by the Knight CRRC and OHSU IRB, as appropriate for the study modification, in collaboration with the principal investigator, and active management of the project throughout the review process. This role is responsible for managing all communications with the review boards, sponsor and other involved parties (e.g., IND/IDE Associate), along with study tool (flowsheets, VIA Oncology, Bridge Regulatory Dashboard) updates. Maintain records on each study to ensure regulatory compliance with institutional policies and ICH/GCP guidelines.
Active management of all other regulatory obligations including preparing continuing review questionnaires (CRQs), and reportable new information (RNI) reports in accordance with institutional policies, sponsor requirements and other regulatory requirements.
Prepare for and liaise with sponsor representatives: Attend study initiation meetings, coordinate monitoring visits, communicate specific study requirements to the research team, preparation for and coordination of study audits and inspections, and manage regulatory documentation. Participate in the development of OHSU physician initiated protocols. Assist in monitoring and coordination of OHSU multi-center studies according to protocol.
Recommend, implement and monitor changes in process and policy issues, and provide guidance on meeting regulatory requirements.Support periodic coverage to and across study teams, as delegated by the Clinical Research Manager. This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed.Required Qualifications: Regulatory Coordinator, novice level (Senior Research Assistant): Bachelor's degree and at least one year of relevant experience. Range minimum: $46,000
Regulatory Project Manager, practitioner level (Senior Research Assistant): Bachelor's degree and at least four years of relevant experience. Range minimum: $57,000
Required competencies:

• High degree of attention to detail
• Ability to prioritize and complete multiple tasks at one time
• 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
• Proficiency with computers running Windows and PC applications (e.g. MS Excel, Oracle, Access, Word and PowerPoint)
• Demonstrated excellent customer service skills both on the phone and in person
• Possess energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships
• Critical Thinking skills
• Time management skills

Preferred Qualifications:

• Bachelor's degree with coursework in science
• At least two years clinical trials/research experience
• Project management training
• Minimum of 1 year regulatory experience
• Project management experience
• Experience using project management software (eg, MS Project).

Additional Details: #linkedIN #indeedAll are welcome: 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 aaeo@ohsu.edu.