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    Clinical Research Associate

    Toku Inc
    5+ years
    $120,000 to $150,000 per year
    Remote, USA
    10 July 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Clinical Research Associate

    Company Overview: Toku Inc. develops innovative tools utilizing AI and retinal photography to provide accessible healthcare for the early and accurate diagnosis of health conditions.

    Position: Clinical Research Associate
    Employment Type: OTHER
    Salary Range: $120k-$150k
    Location: Remote

    Who You Are: Toku Inc. is seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team in the fast-paced world of clinical trials. The ideal candidate will have extensive experience in clinical research and will play a crucial role in monitoring clinical trials, ensuring regulatory compliance, and supporting the development and testing of new medical devices.

    Key Responsibilities:

    • Primary Communication Link: Serve as the main contact between Toku Inc. and the Contract Research Organization (CRO). Facilitate communication flow and ensure all parties are informed of trial progress, compliance issues, and protocol deviations.
    • Trial Documentation: Document and report on clinical trial progress, including site visits, trial status, and participant safety.
    • Stakeholder Communication: Communicate effectively with site staff, investigators, and other stakeholders to meet trial objectives.
    • Trial Monitoring: Work closely with CROs to ensure compliance with the trial protocol, clinical objectives, and regulatory requirements.
    • Data Review: Review and verify data collected during clinical trials for accuracy and integrity. This includes checking case report forms (CRFs), consent forms, and other trial documentation against participant data.
    • Document Preparation: Assist in preparing and reviewing trial-related documents, including protocols, investigator brochures, and summary reports.
    • Recruitment Strategies: Participate in developing and implementing recruitment strategies to increase patient enrollment.
    • Site Staff Support: Provide training and support to site staff to ensure compliance with study protocols and regulations.
    • Issue Resolution: Address and resolve any issues that arise during the trial, escalating complex issues to senior staff as needed.
    • Industry Trends: Stay informed of industry trends, new regulations, and best practices in clinical research to enhance job performance and trial success.

    What You Bring:

    • Education: Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
    • Experience: Minimum of 5 years in clinical research, preferably as a Clinical Research Associate or Clinical Research Coordinator. Experience managing software-driven clinical trials and at least 2 clinical trials managing an external CRO.
    • Knowledge: Strong understanding of Good Clinical Practice (GCP) and regulatory compliance guidelines.
    • Skills: Excellent organizational skills, with the ability to manage multiple responsibilities in a fast-paced environment. Strong communication and interpersonal skills, with proficiency in clinical trial management software and Microsoft Office Suite.

    Preferred Attributes:

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

    What We Offer:

    • Salary Range: $120k-$150k
    • Remote Work: Yes
    • Employment Type: OTHER

    Toku Inc. is committed to providing a supportive work environment where employees can thrive and make a meaningful impact on healthcare.

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