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    Clinical Research Associate

    Tigermed
    2+ years
    Not Disclosed
    Remote, USA
    10 Sept. 30, 2024
    Job Description
    Job Type: Remote 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 Opening: (Senior) Clinical Research Associate

    We are excited to announce an opportunity for a (Senior) Clinical Research Associate (CRA) to join one of the fastest-growing CROs. This permanent, home-based position is available in Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, or New Mexico.

    Job Description

    As a Clinical Research Associate, you will be responsible for monitoring clinical trials to ensure compliance with clinical protocols. Your key responsibilities will include:

    • Ensuring research is conducted in accordance with applicable federal regulations and FDA guidelines.
    • Verifying that data quality meets acceptable clinical standards during initial reviews.
    • Protecting the rights and safety of human subjects involved in clinical studies.

    Responsibilities

    Your responsibilities will include:

    • Participating in the investigator recruitment process and conducting initial qualification visits to evaluate the site’s capability to manage and conduct clinical studies.
    • Collaborating with the Study Start-up Group to prepare sites for study initiation, obtaining necessary regulatory documentation and IRB/EC approvals.
    • Performing study initiation activities, reviewing protocols, regulatory issues, and study procedures with site personnel, and providing training on electronic Case Report Form (eCRF) completion.
    • Training site staff on the Electronic Data Capture (EDC) system and verifying site computer systems.
    • Conducting periodic site file audits to ensure compliance with Good Clinical Practices (GCP) and company SOPs.
    • Ensuring adherence to GCP, investigator integrity, and compliance through on-site monitoring visits, including validation of source documentation.
    • Preparing timely monitoring reports and letters using approved forms.
    • Documenting accountability, stability, and storage conditions of clinical trial materials, performing inventory, and managing the return or destruction of unused materials.
    • Reviewing clinical data quality through in-house eCRF data reviews and on-site source verification, and working with sites to resolve data queries.
    • Serving as the primary contact between the company and investigators, coordinating all correspondence, and ensuring timely data transmission.
    • Assisting with final data review and query resolution prior to database lock, and conducting study close-out visits.
    • Attending Investigator Meetings for assigned studies and potentially mentoring new clinical study monitors.
    • Being authorized to request site audits as needed.

    Qualifications, Skills, and Experience

    To be considered for this role, you should have:

    • Knowledge of the clinical research process and medical terminology.
    • Proven experience in monitoring or coordinating clinical trials; clinical setting experience is a plus.
    • Strong written and verbal communication skills for conveying complex ideas to study personnel.
    • Excellent organizational and interpersonal skills.
    • Ability to reason independently and propose specific solutions in clinical settings.
    • Capability to mentor entry-level CRAs.
    • Understanding of electronic data capture and basic data processing functions.
    • Familiarity with current GCP/ICH guidelines applicable to clinical research.
    • Ability to qualify for a major credit card and possess a valid driver’s license for automobile rental.
    • Willingness and ability to travel domestically and internationally, approximately 50-75%.
    • A Bachelor’s degree in a life science field with proven field monitoring experience.
    • Computer literacy and knowledge of electronic data capture systems are preferred.
    • Proficiency in English is required.
    • Work authorization in the United States is required.

    We are an equal opportunity employer and value diversity in our workforce.

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