The mission of Knight Clinical Research Quality & Administration (CRQA) is to foster a supportive environment conducive to achieving the Knight's clinical research mission. CRQA provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.
Work Schedule, Hours, FTE, Salary Range
Schedule: Mon - Fri, 8-5pm occasional evening and weekend hours
Salary Range: commensurate with experience
FTE: 1.0, full-time
Location: SW Moody, Portland
Job Type: Unclassified Administrative
Functions/Duties of Position
The Assistant Director, Knight Clinical Research Quality & Administration, is responsible for directing all major functions and activities related to clinical research quality and administration activities. The Assistant Director is responsible for strategic planning, program development and overall accountability for programs within the CRQA; including protocol review and monitoring, Quality Assurance (QA) auditing, Quality Control (QC) monitoring, FDA regulatory application support, protocol development, EDC database support, data governance, reporting, clinical trials registration, National Clinical Trials Network (NCTN) support and clinical research education and training. The Assistant Director is responsible for monitoring the regulatory landscape and promoting compliance with all applicable institutional policies, state requirements and federal regulations.
The Assistant Director, Knight Clinical Research Quality & Administration, is responsible for upholding a professional, service-oriented, customer-friendly atmosphere within the CRQA team; maintaining a focus on education and development of regulatory understanding as it relates to promoting compliance with policies, procedures and regulations. The Assistant Director, in conjunction with the CRQA team, Knight Leadership, research teams and others, collaborates in the development of both internal and external guidance documents, policies and practices related to the compliant conduct of clinical research within the Knight. The Assistant Director also oversees the development of internal and external facing resources (i.e. Bridge and OHSU webpages); and represents the CRQA and its operations in a variety of internal and external settings.
The Assistant Director, Knight Clinical Research Quality & Administration, actively participates on various Knight and OHSU committees and workgroups to develop and implement policies and procedures to support efficient processes, inspire and support process improvement initiatives and strategically plan for growth and enhancement of the Knight clinical research mission
Minimum of 8 years clinical research experience with minimum of 2 years oncology research experience.
Minimum of 3 years personnel management experience.
Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines (i.e. HIPAA) that govern clinical research.
Ability to translate knowledge into policies and practices.
Experience in regulatory management and policy development.
Working knowledge of Word, Excel, and other Microsoft Office programs.
Demonstrated ability to work with a variety of roles and outside entities.
Excellent record of setting appropriate priorities and time management.
Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal convictions while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view.
Self-starter with ability to work independently but collaboratively as part of a team; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations; ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
Strong critical thinking skills.
Strong problem-solving abilities and multi-tasking capabilities.
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and r...esearch. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm