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    Clinical Research Associate

    Tigermed
    0-3 years
    Not Disclosed
    Denver
    10 July 18, 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, 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

    Position: Senior Clinical Research Associate (SCRA) / Clinical Research Associate (CRA)
    Type: Permanent, Home-Based
    Location: Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, New Mexico

    Role Overview:

    Join one of the fastest-growing CROs as a (Senior) Clinical Research Associate. This role involves monitoring clinical trials, ensuring compliance with clinical protocols, federal regulations, FDA guidelines, and protecting the rights and safety of human subjects.

    Responsibilities:

    Clinical Trial Monitoring:

    • Monitor clinical trials and ensure investigators conduct research per clinical protocol requirements.
    • Ensure data quality on initial review meets acceptable clinical standards.
    • Protect the rights and safety of human subjects involved in clinical studies.

    Investigator Recruitment and Site Management:

    • Participate in the investigator recruitment process.
    • Perform initial qualification visits of potential investigators.
    • Evaluate the site's capability to manage and conduct clinical studies, both clinically and technically.

    Study Start-Up and Regulatory Coordination:

    • Work with the Study Start-up Group to prepare sites for study initiation.
    • Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
    • Coordinate with the Study Start-up Group and site staff to obtain IRB/EC approval of study-specific documents.

    Study Initiation and Training:

    • Perform study initiation activities, including protocol review, regulatory issues, study procedures, and training on eCRF completion.
    • Train site staff on the EDC system and verify site computer systems.

    Compliance and Monitoring:

    • Conduct periodic site file audits to ensure compliance with GCPs and the company's standard operating procedures.
    • Ensure adherence to Good Clinical Practices and investigator integrity through on-site monitoring visits.
    • Validate source documentation as required by the sponsor.
    • Prepare monitoring reports and letters using approved company/sponsor forms and reports.

    Clinical Trial Materials Management:

    • Document accountability, stability, and storage conditions of clinical trial materials.
    • Perform investigational product inventory.
    • Ensure the return of unused materials to designated locations or verify destruction as required.

    Data Quality and Integrity:

    • Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification.
    • Resolve data queries with sites.
    • Review protocols, eCRFs, study manuals, and other related documents as requested by the Clinical Trial Manager.

    Communication and Coordination:

    • Serve as the primary contact between the company and investigators.
    • Coordinate all correspondence and ensure timely transmission of clinical data.
    • Assist with final data review and query resolution through database lock.
    • Perform study close-out visits.
    • Assist with and attend Investigator Meetings for assigned studies.
    • Mentor new clinical study monitors.
    • Request site audits for reasons of validity.

    Qualifications and Skills:

    Education:

    • BS/BA in one of the life sciences.

    Experience:

    • Proven experience in monitoring and/or coordinating clinical trials preferred.
    • Experience in a clinical setting is a plus.

    Skills:

    • Strong knowledge of clinical research processes and medical terminology.
    • Excellent written and verbal communication skills.
    • Strong organizational and interpersonal skills.
    • Ability to reason independently and recommend specific solutions in clinical settings.
    • Ability to mentor entry-level CRAs.
    • Understanding of electronic data capture, including basic data processing functions.
    • Knowledge of current GCP/ICH guidelines applicable to clinical research.

    Other Requirements:

    • Ability to qualify for a major credit card.
    • Valid driver’s license and ability to rent an automobile.
    • Willingness and ability to travel domestically and internationally (approximately 50%-75%).
    • Language: English (required).
    • Work authorization: United States (required).
    • Computer literacy and knowledge of electronic data capture preferred.

    Equal Opportunity Employer:

    We are an equal opportunity employer and value diversity in the workplace.

    This structured format provides a clear, organized presentation of the job description, responsibilities, qualifications, and other key information.

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