TI Sr Clinical Research Assistant Job at Oregon Health & Science University
Department Overview:
Required Qualifications:
As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.
The Knight Cardiovascular Institute Research Coordinator is responsible for various duties related to clinical trials. The coordinator will Identify potential subjects through chart review, discussion with investigator or other mechanisms; assists PI in the identification and eligibility of new protocol subjects; schedules, orders, communicates assessments and appointments. They are responsible for trial implementation for all trials that fall under their specific discipline. The Research Coordinator is also the primary liaison for patients receiving care on a clinical trial and is responsible for the triage of patient needs. They have a strong understanding of the connection between clinical care and the care delivered as part of a clinical research study for patients. They also have a very strong understanding of research regulations and quality data abstraction for research purposes. This position will be primarily supporting trial activities within the Amyloidosis research group.
Function/Duties of Position:
Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, and Problem-Solving.
Responsible for many aspects of clinical trial administration from startup to closeout and assuring appropriate conduct of protocols to FDA guidelines. This includes but is not limited to:
- Collaborating with the Senior Research Coordinator regarding regulatory requirements of the study and creation of necessary sponsor, KCVI, OHSU and internal clinical trial documents and tools that facilitate study efficiency and team communication.
- Coordinating with the assistants in the collection and transcription of all source data with guidance as needed.
- Collaborate with study team to identify and develop new study-specific processes; ensuring everything is in place for first subject
- Responsible for direct sponsor correspondence in regards to enrollment numbers and general study maintenance issues
Responsible for elements of patient visits including but not limited to:
- Independently schedule and facilitate subject assessments.
- Independently performs subject pre-screening and screening.
- Responsible for working with the clinical research assistants to schedule visits.
- Communicating assessments and appointments with study subjects
- Active involvement in the consent process in tandem with the PI.
- Independent direct patient contact to obtain or verify information and working with PI to triage clinical information and patient questions. Direct Collaboration with ancillary departments to make sure all patients receive timely blood draws (PKs), ECGs, vitals (blood pressure, temp, respirations, height, weight) or other study related tasks as needed. Delegation to research assistant as deemed necessary.
- Provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.
- Ensure all documentation post-visit is entered into EPIC and EDC
- Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc.
Assist the Clinical Trial Manager and Team Leads with other research related projects and administrative/office related duties as needed
Required Qualifications:
- Bachelor’s Degree with major courses in field of research/science AND 1 year of relevant experience; OR
- Associate's Degree AND 3 years of relevant experience; OR
- 4 years of relevant experience
As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.
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