Regulatory Coordinator

Function/Duties of Position:

This position is under the supervision of Aimee Pierce, MD and the Trials Administrator.  The Layton Aging and Alzheimer’s TI (SRA) Senior Clinical Research Assistant serves as the Regulatory Coordinator for all research studies conducted by the program. This position assists in various study specific activities. 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. The senior research assistant (SRA) is responsible for the overall management alongside the PI and repository leadership. This includes working with the regulatory management team to complete regulatory documentation required by the OHSU IRB and sponsor, creation of study calendars and flow charts,  assisting in the verification of patient eligibility, development of data collection instruments and consent forms, data entry, assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines, maintenance of study patient records and source documentation, coordinating orders and study drug with the clinical team.

 

Regulatory Coordinator Responsibilities:

• Study start-up documentation collection
• Create, collect and complete regulatory documents for all research studies
• Collect signatures from relevant personnel on various regulatory documents
• Communicate with pharmaceutical companies, OHSU research team, and other OHSU departments involved with the conduct of research studies
• Coordinate and document necessary study training with OHSU research team and other OHSU departments involved with the conduct of research studies
• Provide complete and accurate regulatory documents to pharmaceutical companies prior to study initiation
• Document Management
• Keep all ongoing documents for all studies up to date and ready for monitoring visits, including both hard-copies and electronic copies
• Keep track of and organize documents such as IRB approval Memos, IRB Approved ICFs, Sponsor Communications, DSMB Reports, Safety Reports, etc.
• Maintain all staff documents such as CVs, license, GCPs, and assessment certifications
• Maintain lab and pharmacy documents
• Keep regulatory binders organized and in good working condition
• Maintain tracker for regulatory documents for protocol trainings
• Submissions include modifications, continuing review, reportable new information, protocol deviations and study close-outs.
• Maintain reminders

General Research Assistant Responsibilities:

• Schedule research patients for follow-up
• Coordinate with other departments
• Assist schedule needs
• Assist with MRI uploads
• Assist with PET ordering
• Assist with data entry needs
• Assist with ClinCard
• Assist with communicating with participants to ensure needs are met
• Back up coordinator needs.
• Ordering investigation product
• Scheduling RPS for pharmacy
• Assist with essential log needs
• Assist with study participant needs
• Assist with maintenance of ordering of supplies

Main responsibility for Florence e-Regulatory Binder

• Ensures regulatory compliance
• Work with regulatory management team to adhere to regulations at OHSU for initial and continuing regulatory approval of clinical protocols such as annual re-approval/continuing review, amendment approval; and submission of reportable information. 
• Be knowledgeable about clinical research protocols and protocol requirements.  
• Distribute clinical research related information to appropriate research team / affiliated institutional personnel as applicable. Notify research team and those individuals directly involved in in pertinent areas of clinical research of protocol amendments, revisions, activations, closures and announcements.
• Keep local Principal Investigator up to date on key information as related to the clinical research. Schedule and maintain records on appropriate trainings/meetings as needed. 

Required Qualifications:

• Bachelor’s Degree in relevant field AND 1 year of relevant experience OR Associates AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience
• 6 months of IRB experience
• Previous work in research
• Strong interpersonal skills
• Commitment to working in a team environment
• Excellent written and verbal skills
• Highly organized and able to work independently
• Strong attention to detail and problem solving skills
• Able to perform the essential functions of the position with or without accommodation
• Ability to be flexible and adaptable to changes in the day-to-day workflow
• Working knowledge of Microsoft Office
• Ability to sit for long periods of time

Preferred Qualifications:

• Working knowledge of Macintosh computers
• Familiarity with clinical research, medical terminology, and clinical contact with patients

Additional Details:

• Typical schedule: M-F
• Work schedule may vary depending on job/study requirements

All 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.