The TI Clinical Research Associate is a highly organized and motivated clinical research professional who is a study coordinator and assists with research operation efforts for the Busui Research Team. The position partners with Dr. Rodica Busui to establish the program’s focus on diabetes related research across the OHSU community and external partners.

 

The TI Clinical Research Associate helps to establish and formalize relationships with regional and national research collaborators. The position works on multiple ongoing studies related to Diabetes and Diabetes Complications, as well as assisting with management of research grants and contracts in collaboration with administration from the Department of Medicine. The position will manage, with oversite from the Division Research Project Manager, a research group of study coordinators, volunteers, and student workers, including onboarding and training new staff, leading group meetings, and coordinating research efforts at other project sites.

 

The TI Clinical Research Associate will be responsible for protocol regulatory oversite and ensuring high quality data collection. The TI Clinical Research Associate will assist with submitting grant applications to federal, industry, and foundation sponsors, with responsibility for budget development and negotiation, collaborating on proposal development, and specific application requirements. The TI Clinical Research Associate will assist with management of awarded funding, ensuring compliance with federal and sponsor-specific policies. This position will also support the growing research efforts at the division level from a collaboration, training and best practices sharing standpoint.

Research and protocol administration: In collaboration with PI and Division Research Project Manager, plans and conducts experiments, submitting to applicable IRB, coordinate sub awards and sub-contractor and services as a research compliance expert.  With occasions oversite performs all research administration required for PI awards and works to assist collaborating PI’s as needed. Collaborates in development of research protocols and IRB proposals. Oversees execution of multiple research protocols by study coordinators. Assists with study interventions and assessments, research subject visits, and data collection, including biologic samples. Coordinates study activities with clinical units, Research Pharmacy, OCTRI, etc. as needed. Organizes and maintains study records. Assists with site initiation and monitoring visits and FDA audits as needed. Ensures compliance with all protocol and regulatory requirements and help prepare required submissions and reports. Ensures compliance with ClinicalTrials.gov reporting.

 

Clinical Trial Coordination: Screen, recruit, and consent participants for interventional and observational outpatient clinical trials related to diabetes research. Carry out study interventions and assessments, research subject visits, and data collection, including biologic samples. Coordinate activities with clinical units, Research Pharmacy, OCTRI, etc. as needed. Perform electronic data entry and trial audits in study-specific databases and OHSU eCRIS. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed.  Assist with site initiation and monitoring visits. Assist with training other research staff on study protocols. Recognize adverse events, protocol deviations, and other study problems and report to PI or senior staff appropriately within GCP and HIPAA guidelines and institutional and sponsor requirements.

 

Publication and presentation of study results: In collaboration with management, plays a key role in producing content and preparing manuscripts and research reports, including writing, editing, graphics, and formatting. Documents and presents data identification, extraction, analysis, and findings to the PI and team members. Help to present data at local and national conferences

 

Personnel Management: Works with Division Manager and Division Research Project Manager for training and onboarding of study coordinators, student workers, and volunteers. Assists with prioritizing daily work and effort on ongoing research awards.  Leads group meetings.

 

Grants financial management: Assists the Division Research Project Manager to develop budgets for grants and industry-sponsored trials and help to manages and track research project budgets and expenditures for currently funded studies as needed and at least quarterly, including validation of personnel and other expenses, and budget forecasting. Will work in collaboration with administration from the Department of Medicine research and central finance pods to ensure research finances best practice.

 

Other Responsibilities. Other duties as assigned.

 

• 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 experience.
• SoCRA or ACRP required within 12 months of hir

 

• Clinical research experience; experience with data collection, management, and analysis.
• Strong organizational skills and attention to detail.
• Demonstrated ability to take initiative and complete projects independently or lead a team.
• Excellent communication, both written and verbal with fluency in English. Strong computer skills and advanced MS Office skills.
• Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review.
• Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols.
• Understanding of best practices for clinical research, including research ethics.
• Project management skills, including use of management/organizational technology.
• Degree in Public Health; coursework in qualitative research, biomedical and/or human subjects research, biostatistics
• Experience managing federal and industry funding
• Working knowledge of FDA IDE/IND submission process, ONCORE, and experience with REDCap.
• Familiarity with electronic medical records (preferably EPIC), chart review and medical terminology.
• HR-related competencies including screening, interviewing, and onboarding research staff.

 

Eight-hour work day Monday through Friday. Schedule may vary depending on study requirements and may infrequently involve working evenings or weekends. Travel as needed for meetings. Duties will be performed on-site in OHSU clinics, and at times remotely as agreed upon with the supervisor. Exposure to human specimen.

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.