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.

• 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, 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.
  • Responsible for communicating with patients regarding scheduled appointments
  • Independently work with monitoring groups to ensure all data is captured as per protocol
  • Consent patients for procedures while they are in-patient
  • Observe, document, and facilitate all research aspects of procedural days involving study subjects – including device accountability, scrub procurement, and coordinating with external partners and providing access to OHSU. 
• Assist the Clinical Trial Administrator or Principle Investigator with other research related projects and administrative/office related duties as needed
  
  • Supporting sponsor visits (i.e. proctoring visits, monitoring, site initiation, etc.)
  • Work professionally with sponsor monitors to coordinate data cleanliness and EDC entry while conducting on-site monitoring. 
  • BLS Certification required 
• Recommend, implement and monitor changes in process and policy issues, and provide guidance on meeting regulatory requirements in oncology clinical research. 

• Bachelor’s in relevant field and 1 year of relevant experience
  OR
• Equivalent combination of training and experience.
• One-year clinical trials experience
• One-year regulatory 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.
• High level of organization, attention to detail, troubleshooting, and prioritizing skills
• 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.
• Ability to use tact and diplomacy to maintain effective working relationships

• Previous employment within a cardiovascular clinical area
• Degree with coursework in science
• Project management training
• Working knowledge of CTMS systems
• Working knowledge of multiple sponsor EDCs
• Working knowledge of OHSU IRB
• Proficient in Microsoft platforms
• Microsoft 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

Location: Marquam Hill & South Waterfront Campus
Schedule: Monday – Friday, 6am – 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As a salaried employee Project Coordinators are expected to flex their time in conjunction with OHSU policy to ensure all deliverables and regulatory timelines are met within their portfolio of clinical trials.

 

Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research Coordinator will be expected to travel to conferences, new study meetings. Clinical Research Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires succesful completion of BLS certification.

 

This is a hybrid role with both patient facing and extensive computer work required. Limited remote work is approved on an as needed basis by Clinical Trial Administrator. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times – this severely restricts the ability to conduct work remotely.

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.