As a Senior Research Assistant, this individual is responsible for clinical, administrative, and educational research activities related to the management of patients on clinical trials. The primary assignment of this position is to serve as the regulatory coordinator for the Womens Health Research Unit. The position is responsible for the oversight and management of all regulatory aspects of research administration for the Department of Ob/Gyn in addition to coordinating or co-coordinating clinical research trials. As a senior position, this position is responsible for assisting with mentorship and training of new and existing Research Assistants in WHRU as their positions relate to coordination of clinical trials. The appointee shall provide services as assigned by the supervisor in furtherance of the universitys missions and goals of teaching, research, patient care, outreach and public service. Position may require travel to off-site partnership locations around the state of Oregon. Weekday position that includes weekend and holiday call coverage: may be required to work evenings or weekends to cover outreach events or call coverage on or off campus. Appointee will be in contact with human tissues & fluids and will be responsible for fluid and tissue collection as related to study protocol. Training will be provided for proper handling, processes, and procedures
Key duties and responsibilities:
Clinical Trials Management: Supervision of womens health clinical research trials at OHSU and other affiliated hospitals including maintenance and submission of patient data, analysis and evaluation of protocol activities, maintenance and preparation for quality assurance audits and management of investigational drugs.Also includes all data management on assigned studies. Requires strong understanding of research protocols and regulations.
Patient Contact: Responsible for patient interactions as outlined in protocol and as delegated by Principal Investigator. Perform participant interviews and physical measurements, including but not limited to blood pressure, heart and respiratory rates, and specimen collection(s).
Regulatory Compliance & Administrative: Primary contact for all faculty, residents, students, and staff for eIRB submissions. Responsible for reviewing and providing feedback on protocols and regulatory documents for faculty and resident initiated projects.Mentorship and training of all staff on regulatory aspects of clinical trials management. Resource for study team in clinical trials.gov and IRB submissions.Management of clinicaltrials.gov. Maintenance and submission of patient data and preparation for quality assurance audits and monitoring. Data management on assigned studies.Assist in the preparation of data for statistical analysis. Assist in conducting statistical analyses of collected data. Contribute to manuscripts, presentations and grant applications.
Outreach: Assist in marketing or advertising outreach efforts as assigned and supervised by unit manager.
Bachelors Degree with major courses in field of research and 1 to 3 years of relevant experience , OR
AA/RN (2 yr) and 3 years of relevant experience
Relevant experience should include regulatory and research experience
Able to appreciate and cultivate a diverse study population
Excellent eye to detail and organization skills
Clinical trials experience strongly preferred
Womens Health specific experience
2 years of regulatory experience
3-5 years research experience
Previous work with physicians in an academic environment
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@example.com.
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 research. 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