The Knight Cardiovascular Institute Research Project Coordinator acts as a key staff member to our Cardiology Clinical Trials program. They are assigned a focused area of cardiovascular medicine with a moderate sized portfolio of clinical studies to assist the PI, Trials Administrator, and Trials Medical Director with managing protocol, regulatory, budgetary, and clinical deliverables. They are expected to coordinate project(s) with active management of expectations, timelines, and deliverables through facilitation and coordination of steps. Track and report milestones. Importantly, they will facilitate program improvements of internal reports and process improvements, including EMR documentation, creation of source documents, and regulatory documents for regulatory submissions.
Additionally, a successful candidate will be able to both support ongoing training of and task oversight of the TI clinical research coordinators who are assigned primary and assistant coordinators to trials they are also responsible for various duties related to clinical trials. They will work alongside the research coordinator(s) and identify potential subjects through chart review, discussion with investigator or other mechanisms; assists PI in the identification and eligibility of new protocol subjects. They are responsible for trial implementation for all trials that fall under their specific discipline. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects.
The successful candidate will have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research. Strong organizational, interpersonal and writing skills are required. Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time is necessary. Attention to detail, strong understanding of the scientific method, project management, customer service, and critical judgment skills are essential. Requires general supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements; above average time management skills.
Required Qualifications Bachelor’s in relevant field and 1 year of relevant experience OREquivalent combination of training and experience.One year clinical trials experienceOne year regulatory experienceVery Strong understanding of Research Regulations and best practicesStrong data abstraction and project management skillsAbility to prioritize multiple tasks at one timeStrong teaching skills with the ability to mentor junior staffMust have 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.High level of organization, attention to detail, troubleshooting, and prioritizing skillsMust be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).Must have demonstrated excellent customer service skills both on the phone and in person.Demonstrated ability to work with a variety of diverse individuals and personalities.Must possess energy and drive to coordinate multiple projects simultaneously.Ability to use tact and diplomacy to maintain effective working relationships Preferred Qualifications Previous employment within a cardiovascular clinical areaDegree with coursework in scienceProject management trainingWorking knowledge of CTMS systemsWorking knowledge of multiple sponsor EDCsWorking knowledge of OHSU IRBProficient in Microsoft platformsMicrosoft office, medical terminology, analytical skills, trouble shooting skills. Ability to thrive within a team environment while holding oneself accountable to deliverables while working independently.BLS All are welcome 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.