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Form of workThe Division of Pediatric Hematology/Oncology (PHO) is a medium-sized program, treating about 150 newly-diagnosed cancer patients per year, and with several hundred patients on active treatment and in follow-up. Many of these patients are participating in clinical trials. Thus, Clinical Research is integral to our clinical program. All work done by our Clinical Research personnel 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 sits within the Department of Pediatrics at Oregon Health & Science University (OHSU) and is closely aligned with the OHSU Knight Cancer Institute. Our program is an active member of the Children's Oncology Group (COG), a cooperative group overseen by the NCI with about 206-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.
We are seeking a Clinical Research Associate (OHSU classification: Therapeutic Interventional (TI) Clinical Research Associate) who will be responsible for assisting with various duties to facilitate oncology Clinical Research. Under occasional supervision, they will coordinate the details of therapeutic interventional* research studies and protocol documentations, patient scheduling, and data collection.
* Therapeutic Intervention 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, cell therapies, devices, experimental approaches to surgery or radiation therapy, etc.
Function/Duties of PositionThe TI Clinical Research Associate (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.
Required QualificationsEducation and experience:
Master's Degree in relevant field AND 3 years of Clinical Research coordination experience ORBachelor's Degree in relevant field AND 5 years of Clinical Research Coordination experience.
SoCRA or ACRP required within 12 months of hire.
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
- Proficiency with computers running Windows and PC applications e.g. MS Excel, Word and PowerPoint
- Excellent customer service skills
- Ability to work with a variety of diverse individuals and personalities
- Energy and drive to coordinate multiple projects simultaneously
- Ability to use tact and diplomacy to maintain effective working relationships
- 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
- Familiarity with Good Clinical Practices (GCP), HSR (Human Subjects Research), RCR (Responsible Conduct in Research)
- Familiarity with regulations related to Clinical Research
- Familiarity with Quality Improvement, Quality Assurance and Quality Control
Please submit a resume and cover letter for your application to be considered.
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All are welcomeOregon 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.Employment Type: OTHER
