The division of PHO is a medium sized program, treating about 150 newly diagnosed cancer patients a year, and with several hundred patients on active treatment and in follow-up. Many of these patients are participating on clinical trials. Thus, clinical research is integral to the clinical program. All work by the CRA ensures the scientific integrity of the data collected, and the protection of the rights, safety, and wellbeing of human research subjects. The Division of PHO is a member of the Childrens Oncology Group (COG), a cooperative group overseen by the NCI with about 250 member institutions worldwide. The Division is also member of several smaller consortia, including TACL (Treatment Advances in Childhood Leukemia and Lymphoma) and PNOC (Pediatric Pacific Neuro-Oncology Consortium), and also participates in industrial sponsored and investigator-initiated clinical trials.
The Clinical Research Assistant (CRA) may be involved in all facets of clinical research, from initial clinical trial development through trial closure and project completion. Clinical research conducted within the Division of Pediatric Hematology/Oncology (PHO) includes cooperative group (National Cancer Institute [NCI] or consortia sponsored), pharmaceutical (industrial sponsored), and local investigator initiated clinical trials.
This position requires independent performance of assignments of significant complexity. This position works with people at all levels of the organization and interacts with numerous internal OHSU departments and external customers (sponsors, monitors, referring physician offices). Duties and schedule may vary at any given time on as needed basis.
The CRA is responsible for all phases of study coordination including pre and post study needs. Regulatory responsibilities are a part of the position, the CRA will collaborate with the PHO regulatory CRA to ensure regulatory compliance of all assigned clinical trials including QA/QC/QI and corrective action plans. The CRA is expected to become proficient quickly in each of his/her assigned protocols. Primary duties include enrolling eligible subjects onto clinical trials, obtaining and submitting all required subject samples and data within specified timelines, maintaining study related documents in an "audit-ready" fashion, data entry in applicable systems, and interacting with external sponsors, monitors and auditors, and coordinating site visits. The CRA is responsible for participating in the Knight Cancer Institute audits and other audits. The CRA will maintain collegial and collaborative relationships with all PHO CRAs, principal investigators (PIs), and various other individuals, to ensure the safe and ethical conduct of all studies.
Note: this is not a Lab position (wet lab)
Bachelors Degree with major courses in field of research and 1 to 3 years relevantexperiencein clinical research.
Ability to type quickly and accurately on a QWERTY keyboard, moderate to advanced computer skills in Excel, Word, proficient with email and the Internet.
Ability to compile/organize and to keep clear, accurate, precise, complete and organized written and electronic records.
Excellent written and verbal communication skills, including the ability to communicate effectively with medical personnel
Ability to work professionally within all levels of an organization and to work effectively both independently and as part of a team.
Ability to learn quickly, retain, synthesize and apply information, follow detailed directions, and become proficient with appropriate systems and standard operating procedures.
Excellent memory: long and short term, with quick recall for both text and numbers, math skills for clinical applications (ie % calculations, dose calculations, volume calculations)
Strong independent analytical skills, meticulous attention to detail, and refined trouble-shooting skills
Familiarity with and application of medical terminology
Ability to work efficiently and effectively and meet deadlines in stressful, time-sensitive situations
Aflexible style with excellent time management and multi-tasking skills and the ability to prioritize and organize a high-volume workload with a consistent high quality work output
Ability to provide excellent customer support to internal and external clients.
Ability to maintain confidentiality of information.
Professional attitude and demeanor.
Neat, legible handwriting.
Major courses in sciences.
Experience as a clinical research assistant in pediatric or medical oncology.
Prior experience abstracting patient data from electronic medical records systems like EPIC.
Familiarity with medical terminology specific to pediatrics, hematology, oncology, and blood and marrow stem cell transplantation strongly desired.
SOCRA or ACRP certified.
Note: this is not a Lab position (wet lab)
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 firstname.lastname@example.org.
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm