TI Sr Clinical Research Assistant - Military veterans preferred

Oregon Health & Science University

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.


TI Sr Clinical Research Assistant

US-OR-Portland

Job ID: 2024-29278
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Marquam Hill)

Overview

• 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
  • Independently work with monitoring groups to ensure all data is captured as per protocol

• 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.
• Ability to use tact and diplomacy to maintain effective working relationships.

• 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.

PI239490028