This position will provide support for research on telehealth delivery of an intervention for dementia family caregivers. May be located in a shared service/core or work directly under a Principal Investigator or Research Manager. Involved in conduct of human participants research, the development and/or management of regulatory compliance with clinical research protocols.
The Clinical Research Associate will assist with regulatory compliance; participant recruitment, screening, consent, enrollment, scheduling and retention; management of surveys and survey distribution. They will support all other team members (PI, Project Director, Research Coordinator, interventionists, Guides, tech team, data team) in schedule management, protocol compliance and effective communication.
Previous human subjects research experience required. Strong interpersonal communication skills and excellent attention to detail a must. Flexibility in managing multiple schedules. Ability to complete detail-oriented duties while working closely with participants, investigators, study staff and external organizations. Must have ability to integrate information from multiple sources. This work requires use of independent judgement, problem-solving skills and diligent time management. Personal transportation for community activities required.
General Scope: Under occasional supervision, coordinates complex clinical research protocols. Contribute to research and assist with study protocol development. Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Oversees and monitors research data to maintain quality.
Exercises judgment within defined Good Clinical Practice and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures (Institutional Review Board) in addressing adverse events as appropriate, protocol deviations, and other unanticipated study problems.
Maintenance and submission of patient data and preparation for quality assurance audits and monitoring.
Data management on studies. May include eIRB and eCRIS submissions.
Educates and serves as an expert resource for other research personnel that may include students residents and fellows. May perform administrative and regulatory duties related to the study as appropriate. Additional duties as assigned.
Required Qualifications Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experienceStrong interpersonal communication skills and excellent attention to detailCritical thinking skills to anticipate and address potential problems Additional Details Typical schedule: M-F, occasional nights and weekends for periodic off-site recruitment events which require personal transportationPossibly national, local travelWill work combination of remote and at the Hatfield Research Center (OHSU Hospital)Work schedule may vary depending on job/study requirementsTravel between meeting locations including using the Portland Aerial TramMay have regular exposure to noise and interruptionsAble to sit at a computer without a break for 60 minutesUse of videoconferencing equipment following privacy laws 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.