The Knight Cardiovascular Institute Clinical Senior Research Assistant (Research Coordinator) is responsible for various duties related to clinical trials. The research 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 experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects.
The research coordinator will have a very strong understanding of research regulations, reporting timelines, and quality data abstraction for research purposes. This position will primarily support our Hypertrophic Cardiomyopathy research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute.
Function/Duties of Position
Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving.
Responsible for many aspects of clinical trial operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:
Collaborating with the clinical trial administrator, program manager, 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.
Reviewing a weekly task list of outstanding items prepared by the assistant coordinator to ensure data entry to EDC is captured within obligatory time frames
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
Data entry of visit data into central data repositories (eCRIS, internal subject trackers, etc.)
Addressing all imaging and laboratory queries in sponsor ERT
Maintaining laboratory reporting and signature requests from the PI
Timely and complete adverse event reporting
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 utilizing the electronic medical record system to document all communications and instructions regarding research visits
Active involvement in obtaining and documenting informed consent
Independent direct research subject contact to obtain or verify information while working with PI to triage clinical information and patient questions.
Direct Collaboration with ancillary departments to ensure research subjects receive timely blood draws (PKs), ECGs, vitals (blood pressure, temp, respirations, height, weight), ECHO, imaging, 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
Independently write Clear, concise, and professional documentation into EPIC for source document creation
Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc.
Assist with coordination of patient travel
Assist with prepping any necessary documents prior to the visit
Responsible for communicating with patients regarding scheduled appointments
Assist with processing and shipping lab specimens
Assist with retrieval of study drug for visits
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
Very Strong understanding of Research Regulations and best practices
Strong data abstraction and project management skills
Ability to prioritize multiple tasks at one time
Strong teaching skills with the ability to mentor junior staff
Must 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.
Must 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.
Bachelor's degree with coursework in Science
At least one year general office experience
Knowledge of cardiology. Managing Access database or similar database.
Microsoft office, medical terminology, analytical skills, trouble shooting skills. Ability to work independently as well as within a team enviroSnment.
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 [email protected].
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