TI. Sr Clinical Research Assistant at Oregon Health & Science University in Portland, Oregon

Job Description:

Oregon Health & Science University

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.


TI. Sr Clinical Research Assistant

US-OR-Portland

Job ID: 2024-32150
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Waterfront)

Overview

These responsibilities include assisting with components of the IRB submission, to include preparation of consent forms and other documents required for IRB review. On-study duties include the coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be subject safety and compliance with the prescribed protocol and Good Clinical Practice. The CRC will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities. The CRC will maintain accurate, complete and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms. The CRC will ensure that patient billing is accurate and assist manager and financial team in verifying appropriate clinical trial billing for very complex oncology trials. This requires the CRC to have a solid understanding of the study financial lifecycle and how their work directly impacts this. The CRC may have direct patient contact, process biological samples and may perform other non invasive testing such as ECGs. The study coordinator will also assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.

The CRC will represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The CRC will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. Additionally, the CRC is required to learn and remain up to date on the oncology disease sites their team manages. This includes understanding the basic disease processes and current standard of care therapies used for each disease site. The CRC must be able to apply this knowledge to the tasks they are assigned.

Given the complexities of oncology research and the challenges of working with a terminally ill population, strong customer service, organizational, and interpersonal skills are required. Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time is necessary. Attention to detail, service orientation, delegation and project management skills, and above average critical judgment skills are essential.

Under minimal supervision, coordinates complex therapeutic interventional clinical research protocols and data management. Contributes to feasibility assessment and research protocol management. Ensures research protocol implementation. 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.

Responsibilities

Education & experience:

• Bachelor's Degree in relevant field AND 1 year of relevant experience OR
• Associate's AND 3 years of relevant experience OR
• 4 years of relevant experience OR
• Equivalent combination of training and experience.

Knowledge, skills, and abilities:

• Ability to prioritize multiple tasks at one time.
• Excellent communication, analytical and organizational skills: both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Intermediate skills with Microsoft Office (Excel, Outlook, Access, Word, and PowerPoint) on Window OS.
• Must have demonstrated excellent customer service skills both on the phone and in person.
• Must possess energy and drive to coordinate multiple projects simultaneously.
• Ability to use tact and diplomacy to maintain effective working relationships

Qualifications

Education & experience:

• Direct clinical research experience
• Research experience with some knowledge of clinical trials
• Experience coordinating different phases of projects, including data collection
• Customer service experience

Knowledge, skills, and abilities:

• Microsoft Office, Access, and/or other networking and database systems
• Medical terminology
• OHSU systems such as Oracle and/or Epic
• CCRP or ACRP Certified

PI254136949

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