TI Clinical Research Assistant II

Company : Oregon Health & Science University

Department Overview:

Under general supervision, assists in coordinating the details of therapeutic interventional research studies and protocol documentations, patient scheduling, and data collection. Assists in complex studies. Works under the direction of a Principal Investigator, Research Manager/Program Administrator, Division Manager and Senior team members. Will provide assistance to coordinate and conduct multiple research protocols in a team setting. Will involve working closely with multiple OHSU clinical and research areas, including the research pharmacy, the Epic team, and the clinical research billing office. Will interface and work with industry sponsors to ensure proper and compliant study conduct. Works closely with research and clinical investigators and team members across multiple sites to ensure the safety of research participants. Is able to set priorities and timelines for complex research activities.

Exercises judgment within defined Good Clinical Practice and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures (Institutional Review Board) in recognizing adverse events, protocol deviations, and other unanticipated study problems and reports to senior staff appropriately. May assist with project logistics and all parts of research program coordination or management, in coordination with other OHSU clinical and research departments. May collate, enter, and present research data for analysis. May assist with administrative and regulatory duties related to the study as assigned. 

Must have excellent communication, organization, and customer service skills, and must be a self-starter with ability to work well in a team environment. Familiarity with health record database systems is helpful. Responsible for patient assessment for protocol eligibility, counseling of patients regarding study schemas; study calendar and treatment plan; thorough written tracking of patient visits’ for billing purposes, patient education; coordinating follow-up care and liaison between patients and other members of the healthcare research team. Will be responsible for the coordination of multiple research studies for the Rheumatology Research team including maintenance and submission of patient data; evaluation of protocol activities; maintenance and preparation of quality assurance audits, and management of investigational drugs. Ensures timely completion of work for all assigned trials. 

Function/Duties of Position:

• Coordinates with OPAM and Contracts office during budget and contract negotiation process
• Coordinates with DoM office and OPAM for account maintenance, invoicing, and reconciliation.
• Actively screens and consents patients for the studies and conduct study visits. This will include coordinating appointments with the PI and/or sub-PI as needed.
• Submit modification approvals to the IRB and complete all other IRB reportorial requirements
• Completes electronic data entry for research patients in a timely manner
• Maintains and organize study binders, as well as prepare for site visits and meet with monitors.
• Participates in recruitment activities for active studies.
• Coordinates care of research patients with their specialists/PCPs

Required Qualifications:

• Bachelor's in relevant field OR
• Associate's AND
  2 years of relevant experience OR
  3 years of relevant experience OR
  Equivalent combination of training and experience
• Must have excellent communication, organization, and customer service skills, and must be a self-starter.
• Proficient knowledge of Microsoft Office Suite (including Word, Outlook, and Excel); strong organizational skills; excellent oral and written communication skills; meticulous detail to data and study procedures; ability to prioritize work demands and trouble shoot; ability to work independently in a multi-task environment. Familiarity with health record database systems is helpful.

Preferred Qualifications:

• Bachelor’s degree with major courses in the field of research is preferred.
• Prior research experience in a university setting.
• Prior clinical research experience in a complex health system or university setting

• Basic clinical examination & vital signs assessment is preferred.

•  

  Phlebotomy training is preferred.

•  

  Familiarity with health record and research database systems.

Additional Details:

• General work schedule will be a flexible Monday – Friday shifts (5 days per week). Environmental exposures include working with lab reagents, human tissues (blood and saliva), and general patient contact. Hybrid (remote and in-person work) is allowed but is dictated by patient visits, patient care needs, and PI schedules. Schedules are discussed and assessed weekly with the larger team to determine support for in-person to-dos.

• Ability to work at a computer for up to four hours at a time. Ability to move around the campus as needed for research studies and meetings. Ability to lift up to 25 pounds.

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 (phone number removed) or aaeo@ohsu.edu.

Apply Online