Oregon Health & Science University·Portland, Oregon
Facilitate oncology clinical research by managing regulatory documentation, verifying patient eligibility, and coordinating study drug administration. Act as a liaison between the clinical care team, pharmacy, and research participants while ensuring protocol compliance.
Department Overview The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment.
The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures.
This fast-paced and highly intense research environment requires management of complex therapeutic interventional (TI) trials and clinical research studies involving a very vulnerable and sick population.
Therapeutic Interventional (TI) trials are treatment studies that involve people who have a disease or underlying condition.
They include the administration and testing new treatments or new ways of using existing treatments, such as new drugs, vaccines, or Cell Therapies.
Function/Duties of Position OHSU classification: Therapeutic Interventional (TI) Senior Clinical Research Assistant (temporary) This is a temporary position, with an expected duration of 3-6 months.
Not a benefit-eligible position.
This Clinical Research Assistant is responsible for assisting with various duties to facilitate oncology clinical research on the Thoracic team in the Knight Clinical Research Management organziation.
Responsibilities include: Working with the regulatory management team to complete all regulatory documentation in accordance with their role as required by the OHSU IRB and sponsor Creation of study trackers and organization tools Assisting in the verification of patient eligibility Development of data collection instruments and assistance with regulatory Data entry Assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines Maintenance of study patient records and source documentation Coordinating orders, scheduling and study drug administration with the clinical team Supporting clinical care team with completion of research required tests and assessments Act as liaison between research protocol and clinic staff, pharmacy, and research participants Ensuring that patient billing is accurate and assisting manager and financial team in verifying appropriate clinical trial billing.
Participation in patient consenting Support and periodic coverage to and across study teams, as delegated by the Clinical Research Manager.
This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed.
This TI Clinical Research Assistant will have direct patient contact, process biological samples, and may perform other non-invasive testing such as ECGs.
The TI Clinical Research Assistant 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.
Required Qualifications Education and experience: Bachelor's Degree in relevant field and 1 year of relevant experience OR Associate's and 3 years of relevant experience OR No degree and 4 years of relevant experience OR Equivalent combination of training and experience.
High degree of attention to detail Ability to prioritize and complete 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 Proficiency with computers running Windows and PC applications (e.g. MS Excel, Oracle, Access, Word and PowerPoint) Demonstrated excellent customer service skills both on the phone and in person Possess energy and drive to coordinate multiple projects simultaneously Ability to use tact and diplomacy to maintain effective working relationships Critical Thinking skills Time management skills Every Knight Cancer employee is expected to embody our guiding principles: We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently. We SUPPORT each other—Respect leads to trust, which leads to excellence. We work as a CONNECTED team — We must leverage our collective brain power to conquer cancer because no one individual can do it alone.
Clinical trial knowledge with a minimum of 1 year of research experience Oncology experience Experience conducting different phases of projects, including data collection and 3-5 years of clinical trial experience Networking and database systems Medical terminology Working knowledge of Epic CCRP or ACRP Certification Typing 40+ wpm Additional Details Apply online. Be sure to include a cover letter and resume/CV. Why apply to OHSU? We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington. All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu
Requires a Bachelor's degree with 1 year of experience, or an Associate's with 3 years, or 4 years of relevant experience. Preferred qualifications include oncology experience, CCRP or ACRP certification, and proficiency in Epic.
Market context
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