TI Clinical Research Assistant

Department Overview

The Clinical Trials Unit supports the vision of the Division of Cardiovascular Medicine, the Knight Cardiovascular Institute (KCVI) and OHSU Health to provide Oregonians with state-of-the-art facilities and outstanding staff to advance treatments for cardiovascular diseases. KCVI and OHSU Health proudly collaborate to support clinical research and bring the future of cardiovascular care to the present. Our clinic, located on the South waterfront in CHH1, supports the complex care initiative and the Healthcare mission's priorities, while the CTU provides in patient trial opportunities and procedural care on OHSU main campus as well. Our unit provides the physical infrastructure to perform pharmacological and medical device trials including trials which require infusions, genetic trials, device implants, and cutting-edge imaging.

 

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 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. This is an onsite role with limited hybrid opportunities.

Function/Duties of Position

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 trials leadership 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 team 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 (CTMS systems, internal subject trackers, ClinCard, PI documents, etc.)
• Addressing all imaging and laboratory queries in sponsor EDC
• Maintaining laboratory reporting and signature requests from the PI 
• Timely and complete adverse event reporting, including SAE

Responsible for elements of patient visits including but not limited to:

• Independently schedule and facilitate subject assessments with support from assistant coordinators.
• 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