Clinical Research Assistant

Function/Duties of Position The Pediatric Clinical Research Office (PCRO) in the Deparment of Pediatrics is searching for a Clinical Research Assistant to join the team. Under general supervision the Clinical Research Assistant 2 is responsible for clinical, administrative, regulatory, and educational research activities related to the management of patients on clinical trials within the Pediatric Clinical Research Office (PCRO) in the Department of Pediatrics. Primary duties include: coordinating multiple clinical research studies; consenting and enrolling patients, gathering data, regulatory tasks, data entry, gathering source documents, basic sample processing and shipping. Additionally, this position will assist the Clinical Research Manager with other projects and duties as assigned. Clinical Trials Management: Assist with the day-to-day research activities of the Pediatric Clinical Research Office (PCRO) to ensure efficient workflow and maximum productivity. Act as a liaison between the PI and sponsoring entity Collect patient source documentation from OHSU and other medical institutions including medical records and lab reports. Record clinical information into appropriate research documents as requested and keeps study records accurate. Input study patient information into study-specific databases Collect and ship research specimens such as blood and samples in compliance with OSHA lab safety requirements. Carry out all assigned clinical activities in compliance with established research protocol and standards. Assist with special projects and perform other duties as assigned Patient Contact Educate on protocol requirements, including visit reminder calls to ensure compliance with study; completes study informed consents, gathers patient data. Regulatory & Compliance Administration Assist with maintenance and submission of patient data and evaluation of protocol activities, maintenance and preparation for quality assurance audits as assigned by the primary coordinator. Assist primary coordinator with data management Must be able to do data entry for extended periods of time Other duties as assigned Provides services as assigned by the supervisor in furtherance of the university’s missions and goals of teaching, research, patient care, outreach and public service Attends regular research meetings Chart review and data collection for subjects enrolled in registries or other clinical trials that need extensive chart review Required Qualifications Associate's AND 2 years of relevant experience OR 3 years of relevant experience OR Equivalent combination of training and experience. Must be able to work independently with minimal supervision, be highly detailed oriented with accurate attention to detail and have excellent organizational and management skills. Must be self-starter and be able to prioritize tasks in fast paced environment. Intermediate and experienced knowledge of Word, Excel, and other MS Office programs. Must be able to speak and communicate clearly, and demonstrate a high level of customer service to other members of the health care team both at OHSU and outside entities. Must be able to appreciate and cultivate a diverse study population. Preferred Qualifications 3+ years of relevant experience. Clinical research experience, including working knowledge of institutional review board (IRB) work. Possesses working knowledge of GCP regulations, ICH guidelines, and FDA regulations regarding human subjects. Ability to perform venipuncture and IV placement for sample collection. Certification from an appropriate accredited certifying body (e.g. ACRP or SOCRA). 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 View email address on click.appcast.io #J-18808-Ljbffr Ohsu-Psu