Research Project Coordinator, Entry

Department Overview

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. This position will primarily support our Structural Heart & Interventional 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 Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving.
  • We keep the patient at the center of every decision
  • We work as a TEAM – providing the patient the best of us
  • We support each other – if we succeed our patients succeed Always Yes
• Responsible for designated clinical trials portfolio management operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:
  • Clinical Trial Study start-up: responsible for creation of all source documentation, EMR process document creation, internal database creation, ensuring all regulatory requirements of the study are in place prior to first enrollment. Creation of necessary sponsor, KCVI, OHSU and internal clinical trial documents and tools that facilitate study efficiency and team communication. 
  • Clinical Trial Financial support: Will support Trials Administrator in creating and documenting invoiceable tracking, study visit charge reconciliation, and CTMS study build.
  • Tracking trial EDCs and reporting to PI/Trials Administrator.  Ensuring TI staff are conducting trial in alignment with reporting mandates as dictated by contracts.
  • Collaborate with study team to identify and develop new study-specific processes; ensuring everything is in place for first subject
  • Direct responsibility for preparation of all documentation required by OHSU IRB, in collaboration with the principal investigator. Active management of portfolio submissions throughout the review process.  This role is responsible for prompt responses and coordination of all communications with the review boards, sponsor and other involved parties.
  • Will provide a bi-weekly report to Trials Administrator, PI, and maintain records on each study to ensure regulatory compliance with institutional policies and ICH/GCP guidelines.
  • Clinical Trial Audit: Will take primary role in guiding TI coordinator staff in preparation of all materials for external audits and/or inspections. Is responsible for management of study binders and completeness. Will partner with Trials Administrator, PI to prepare for and be the face of any audit for a trial within their portfolio.
• Actively manage all other regulatory obligations including 
  • Preparing continuing review questionnaires (CRQs), unanticipated problem (UP) reports, protocol deviation (PD) reports, and reportable new information (RNI) reports in accordance with institutional policies, sponsor requirements and other regulatory requirements.
  • Expeditiously evaluate study modifications and other changes to the conduct of studies within cardiology portfolio to identify feasibility and all downstream impacts to systems in place to support study conduct. Collaborate with all parties directly responsibility for systems and oversee timely completion of deliverables (e.g., Research Pharmacy deliverables, CTMS study build, regulatory document collection, updated source documents)
• Responsible for elements of patient visits including but not limited to: 
  • Independently performs subject pre-screening and screening.
  • 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