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    Clinical Research Associate

    Tigermed
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Title: Senior Clinical Research Associate (SCRA) / Clinical Research Associate (CRA)

    Location: Home-based (Washington/Oregon/Colorado/Wyoming/Montana/Utah/Arizona/Idaho/Nevada/New Mexico)

    Job Overview: An exciting opportunity has become available for a Senior Clinical Research Associate or Clinical Research Associate to join one of the fastest-growing CROs. This permanent, home-based position offers the chance to work in a dynamic and evolving environment. The role involves monitoring clinical trials and ensuring that investigators conduct research in line with clinical protocol requirements and regulatory standards.

    Key Responsibilities:

    • Ensure clinical trials comply with applicable federal regulations and FDA guidelines.
    • Maintain data quality through initial reviews to meet clinical standards.
    • Protect the rights and safety of human subjects involved in clinical studies.
    • Participate in the investigator recruitment process and conduct initial qualification visits to evaluate site capability.
    • Coordinate activities with the site in preparation for study initiation.
    • Obtain regulatory approvals and assist with study-specific documentation.
    • Perform study initiation, monitoring, and close-out activities.
    • Train site staff on EDC systems and verify site computer systems.
    • Conduct periodic site audits for compliance with GCPs and company SOPs.
    • Prepare monitoring reports and maintain accountability for clinical trial materials.
    • Review and resolve data queries in collaboration with study sites.
    • Serve as the primary contact between the company and investigator, ensuring timely data transmission.
    • Assist with data review, query resolution, and database lock processes.
    • Attend Investigator Meetings and serve as a mentor to new clinical study monitors.

    Qualifications, Skills, and Experience:

    • Strong knowledge of the clinical research process and medical terminology.
    • Proven experience in clinical trial monitoring or coordination (experience in a clinical setting is a plus).
    • Excellent written and verbal communication skills to interact with study personnel.
    • Strong organizational, interpersonal, and mentoring skills.
    • Ability to work independently and recommend solutions in clinical settings.
    • Familiarity with electronic data capture (EDC) systems.
    • Knowledge of current GCP/ICH guidelines for clinical research.
    • Valid driver’s license and ability to travel domestically and internationally (50%-75%).
    • BS/BA in a life science field with field monitoring experience.
    • Proficiency in computer literacy and EDC systems preferred.

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