Oregon Health & Science University - Portland, OR

posted about 2 months ago

Full-time - Entry Level
Portland, OR
Educational Services

About the position

The Knight Cardiovascular Institute Research Project Coordinator plays a pivotal role within the Cardiology Clinical Trials program at Oregon Health & Science University. This position is designed for an entry-level candidate who will be responsible for managing a focused area of cardiovascular medicine, overseeing a moderate-sized portfolio of clinical studies. The coordinator will assist the Principal Investigator (PI), Trials Administrator, and Trials Medical Director in managing various aspects of clinical trials, including protocol adherence, regulatory compliance, budget management, and clinical deliverables. In this role, the coordinator is expected to actively manage project timelines and deliverables, ensuring that all milestones are tracked and reported accurately. A significant part of the job involves facilitating program improvements, which includes enhancing internal reports and processes, improving electronic medical record (EMR) documentation, and creating necessary source and regulatory documents for submissions. The successful candidate will also support the ongoing training and oversight of clinical research coordinators assigned to specific trials, ensuring that all team members are aligned with the project goals and protocols. The coordinator will work closely with research coordinators to identify potential subjects for clinical trials through chart reviews and discussions with investigators. They will be responsible for the implementation of trials within their specific discipline, requiring a strong understanding of the differences between clinical care and research protocol visits. A thorough knowledge of FDA, DHHS, and other regulatory guidelines governing clinical research is essential. The role demands strong organizational, interpersonal, and writing skills, as well as the ability to manage multiple priorities and tight deadlines effectively. Attention to detail, critical judgment, and a solid understanding of the scientific method are crucial for success in this position.

Responsibilities

  • Assist the PI, Trials Administrator, and Trials Medical Director in managing clinical trial protocols, regulatory compliance, and budgetary deliverables.
  • Coordinate project timelines and deliverables, tracking and reporting milestones effectively.
  • Facilitate program improvements, including EMR documentation and creation of regulatory documents for submissions.
  • Support ongoing training and oversight of clinical research coordinators assigned to trials.
  • Identify potential subjects for clinical trials through chart reviews and discussions with investigators.
  • Implement clinical trials within the specific discipline, ensuring adherence to protocols and regulatory guidelines.

Requirements

  • Bachelor's degree in a relevant field and 1 year of relevant experience, or equivalent combination of training and experience.
  • One year of clinical trials experience.
  • One year of regulatory experience.
  • Strong understanding of research regulations and best practices.
  • Strong data abstraction and project management skills.
  • Ability to prioritize multiple tasks simultaneously.
  • Strong teaching skills with the ability to mentor junior staff.
  • Excellent communication, analytical, and organizational skills, both written and verbal.
  • Ability to work independently and collaboratively within a team.

Nice-to-haves

  • Previous employment within a cardiovascular clinical area.
  • Degree with coursework in science.
  • Project management training.
  • Working knowledge of Clinical Trial Management Systems (CTMS).
  • Familiarity with multiple sponsor Electronic Data Capture (EDC) systems.
  • Working knowledge of OHSU Institutional Review Board (IRB) processes.
  • Proficient in Microsoft platforms and medical terminology.

Benefits

  • Health insurance
  • Dental insurance
  • 401k retirement plan
  • Paid holidays
  • Paid time off (PTO)
  • Tuition reimbursement
  • Professional development opportunities
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