Clinical Research Coordinator - commute to CDA

Institute for Orthopedic Research and Innovation - Spokane, WA

Full-time | Part-time

CLINICAL RESEARCH COORDINATOR

DUTIES – RESPONSIBILITIES

The Clinical Research Coordinator reports directly to the Executive Director.

The major functions to be performed in this position are as follows:

  • Report and document safety issues (e.g. adverse events);
  • Participate in the preparation or review of documents exchanged with the institutional review board (IRB);
  • Participate in protocol review or study procedures planning;
  • Participate in conducting subject visits;
  • Collect accurate, verifiable data, source documents, and essential documents;
  • Prepare for and participate in sponsor audits and/or regulatory inspections;
  • Participate in the informed consent process;
  • Administratively and clinically manage an average of 2 to 8 clinical trials;
  • Adhere to Research SOP’s;
  • Adhere to the study protocols;
  • Ensure scientific integrity of data and protect the rights, safety, and well-being of patientsenrolled in clinical trials;
  • Discuss study protocols with patients and verify the informed consent documentation
  • Provide patient with written communication of their participation (i.e. copy of the signedinformed consent;)
  • Meet with patient for each visit and maintain accessibility to discuss anyquestions/concerns regarding the study;
  • Schedule all patient research visits and procedures consistent with protocolrequirements;
  • Complete and maintain case report forms per FDA guidelines, and review them againstthe patient’s medical record for completeness and accuracy;
  • Administer questionnaires/diaries per protocol;
  • Submit patient reimbursement requests at the conclusion of patient’s participation inprotocol;
  • Create and maintain patient tracking and scheduling systems in excel, google calendar and electronic medical record (EMR);
  • Ensure the filing and maintenance of all regulatory documents;
  • Coordinate with study locations, providers, and clinical/hospital personnel;
  • Assist in the creation of study materials including but not limited to documents, presentations, protocols, IRB submission, manuscripts, posters;
  • Participate in research meetings and assist in preparation of agendas, minutes, and tracking of action items;
  • Other duties as assigned

DESIRED QUALIFICATIONS

Education BS/BA preferred

  • Knowledge of clinical research principles including GCP and ICH guidelines
  • Certified Clinical Research Coordinator or relevant experience and education may substitute
  • Advanced knowledge of clinical study processes
  • Strong computer literacy in Excel
  • Excellent written and verbal communications skills
  • Highly effective interpersonal and customer service skills
  • Experienced with technical writing

MINIMUM QUALIFICATIONS

Education AA/AS

  • Ability to work independently, problem solve, and demonstrate initiative and follow-through
  • Highly effective interpersonal and customer service skills
  • Strong computer literacy in Microsoft Word, Excel, and PowerPoint
  • Ability to work independently with flexible hours
  • Ability to obtain clinical trial certification through CITI online courses
  • Ability to work from Coeur d’Alene office travel to research sites as needed
  • Exhibit honesty and a high level of integrity
  • Ability to take direction
  • High attention to detail and complete tasks toward completion and accountability

Job Types: Full-time, Part-time

Salary: $19.00 to $24.00 /hour DOE

Job Types: Full-time, Part-time

Experience:

  • relevant: 1 year (Required)

Benefits:

  • Flexible schedule

Schedule:

  • Monday to Friday
  • No weekends
  • Day shift