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Research Studies Coordinator- Huntington Beach

Company: Azul Vision
Location: Huntington Beach
Posted on: September 14, 2022

Job Description:

Azul Vision is the largest eye care practice in Orange County, Inland Empire, and the Los Angeles area, with Twenty-Five locations, and our newest location in Palm Desert, to serve you conveniently and comfortably. Our world-class eye doctors are experts in all aspects of eye care as well as leading specialists in vision correction, cataract surgery, and laser eye surgery. We offer everything from cataract removal to cosmetic procedures such as eyelid surgery. You can rest assured you will receive cutting-edge treatment in a comfortable, friendly, and high-tech environment.
The Research Coordinator: Coordinates, implements, and completes clinical research studies and/or clinical trials by assisting in screening patients, obtaining consent forms, educating participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process, and shipment of research samples, participation in continuous process improvement initiatives.

  • Ensure site readiness for new clinical trials:
  • Conduct contract/budget negotiation with Sponsor/CRO
  • Complete initial regulatory document submissions as required by Sponsor
  • Oversee the training and certification of all study staff
  • Create study source documents
  • Implement pre-screening process for potential candidates, if possible
  • Maintain accountability of study payments and report department revenue to corporate office
  • Perform study procedures in accordance with ICH-GCP regulations and study protocols, which can include, but is not limited to:
  • Consenting patients
  • Medication and adverse event review
  • Refraction
  • Imaging or testing
  • Lab collection, processing, and shipping previous IATA training is a plus
  • Analyze clinic flow to strategically use clinic workup rooms, properly make use of physicians time/schedule, and minimize patients appointment time
  • Oversee research patient visit schedule and modify doctors/tech/staffs schedule to comply with visit window requirements
  • Work collaboratively with the investigators, study vendors, Sponsors, and study monitors to ensure that trial is properly conducted, all data is correct and complete, and study timelines are met
  • Discuss and inform study participants with PI to ensure patient safety and PI oversight
  • Report adverse events/serious adverse events to Sponsor, following Sponsor required deadlines, and follow up as necessary
  • Assess and maintain quality control of subject paper source, electronic subject data, and regulatory documents
  • Cultivate enthusiastic and professional relationships with patients and sponsors alike
    • Problem assessment.
    • Creative problem solving.
    • Interpersonal skills.
    • Leadership abilities.
    • Oral and written communication skills.
    • Proactively sets, meets, and strives to exceed expectations
      • Prior experience as a study coordinator is a MUST
      • Prior experience in ophthalmology is preferred, but not required
      • The position requires at least a high school diploma or equivalent, but individuals with college degrees are preferred.
      • Must possess excellent clerical skills and good interpersonal skills
      • Computer skills related to data management (including MS Office)
      • Experience with electronic medical records (EMR) and other clinical software a plus
      • Friendly attitude and people skills, with an emphasis on being a team player
      • High degree of attention to detail and organizational skills
      • Optimality Technician
        • Excellent verbal and written communication skills
        • Strong interpersonal skills
        • Ability to read and interpret basic business correspondence
        • Strong organizational skills and proven ability to multitask
        • Proactive work ethic and self-starter
          • Strong communication skills
          • Comfortable leading and implement change
          • Strategic
          • Has perspective
          • Proven decision-making and problem-solving ability
          • Ability to build strong positive and enduring relationships internally and externally
          • Confident
          • Flexibility / adaptability
          • Professional
          • Personal integrity
          • Sense of humor
          • Team player
            • Full COVID-19 vaccination is an essential requirement of this role. Azul Vision will adhere to all federal, state, and local regulations as well as all client requirements and will obtain necessary proof of vaccination prior to employment to ensure compliance.
            • Azul Vision requires all new hires and employees to report their COVID-19 vaccination status
            • Employees must comply with any state and local masking orders. In addition, when in an Azul building, employees are expected to always wear a mask.

Keywords: Azul Vision, Huntington Beach , Research Studies Coordinator- Huntington Beach, Other , Huntington Beach, California

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