ExtensisHR

Clinical Research Associate

ExtensisHR La Jolla, CA
ExtensisHR

Clinical Research Associate

ExtensisHR La Jolla, CA
1 week ago 32 applicants

See who ExtensisHR has hired for this role

Toku develops tools using AI and retinal photography to enable accessible healthcare for early and accurate diagnosis of health conditions.

Toku Inc. is seeking a dedicated and detail-oriented Clinical Research Associate to help our dynamic team in the fast-paced world of clinical trials. The ideal candidate will possess extensive clinical research experience and will be responsible for monitoring clinical trials, ensuring compliance with regulatory standards, and contributing to the development and testing of new medical devices.

Key Responsibilities

  • Act as the primary communication link between Toku Inc. and the CRO. Facilitate communication flow and ensure that all parties are informed of trial progress, compliance issues, or any deviations from the planned protocol.
  • Document and report on clinical trial progress, including site visits, trial status, and participant safety.
  • Communicate effectively with site staff, investigators, and other stakeholders to ensure trial objectives are met.
  • Work closely with Contract Research Organizations to monitor the conduct of clinical trials, ensuring compliance with the protocol, overall clinical objectives, and applicable regulatory requirements.
  • Review and verify data collected during clinical trials to ensure accuracy and integrity.
  • Review data collected by the CRO to ensure its accuracy and integrity. This may include checking case report forms (CRFs), consent forms, and other trial documentation against participant data to verify consistency and correctness.
  • Assist in the preparation and review of trial-related documents, such as protocols, investigator brochures, and summary reports.
  • Participate in the development and implementation of recruitment strategies to increase patient enrolment.
  • Provide training and support to site staff to ensure compliance with study protocols and all applicable procedures and regulations.
  • Address and resolve any issues that may arise during the trial, escalating complex issues to senior staff as necessary.
  • Stay informed of industry trends, new regulations, and best practices in clinical research to enhance job performance and trial success.
  • Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience in clinical research, preferably as a Clinical Research Associate or Clinical Research Coordinator or similar role.
  • Previous experience managing software-driven clinical trials.
  • Minimum of 2 clinical trial experience managing an external CRO.
  • Strong understanding of GCP (Good Clinical Practice) and regulatory compliance guidelines for clinical trials.
  • Excellent organizational skills with the ability to manage multiple responsibilities in a fast-paced environment.
  • Strong communication and interpersonal skills, with the ability to work effectively both independently and as part of a team.
  • Proficient in the use of clinical trial management software and Microsoft Office Suite.


Preferred Attributes

  • Accreditation such as CCRP or CCRA.
  • Solid understanding of AI/ML principles and their application in clinical settings.


Salary range $120k-$150k

Remote Work

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Human Resources Services

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