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    Clinical Research Associate

    Icon
    3+ years
    Not Disclosed
    Remote, USA
    10 July 15, 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

    Clinical Research Associate (CRA) Role Overview

    Company Overview

    Join the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

    Key Responsibilities

    • Regulatory Compliance: Ensure regulatory, ICH-GCP, and protocol compliance. Evaluate site performance and provide recommendations. Communicate significant issues and develop action plans.
    • Informed Consent: Verify and document informed consent for each subject/patient. Protect subject/patient confidentiality and assess safety and data integrity.
    • Monitoring Activities: Conduct monitoring activities on-site and remotely per Clinical Monitoring/Study Monitoring Plan (CMP/SMP). Perform Source Document Review and Source Data Verification.
    • Data Verification: Ensure accurate and complete clinical data entry in case report forms (CRF). Manage protocol deviations and follow-up.
    • Query Resolution: Apply query resolution techniques remotely and on-site. Provide guidance to site staff and drive query resolution to closure within agreed timelines.
    • Investigational Product (IP) Management: Perform IP inventory, reconciliation, storage, and security reviews. Verify IP dispensing and administration according to the protocol. Ensure IP compliance with GCP/local regulations.
    • Issue Management: Report identified issues and manage follow-up to resolution. Document activities via required project documents.
    • Site Personnel Management: Ensure site personnel are appropriately delegated and trained. Enter data into tracking systems to track observations and action items.
    • Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to meet project objectives and deliverables. Adapt to changing priorities.
    • Data Entry Review: Review data entry timeliness, missing pages, outstanding data queries, and database lock timelines.
    • Site Log Review: Confirm site signature sheets and delegation of duties logs are up to date. Assess training compliance for site personnel.
    • Site/Facility Check: Ensure site/external facilities, equipment, and supplies are adequate and within expiry dates.
    • Collaboration: Collaborate with the primary Site Manager. Attend Investigator Meetings and sponsor meetings. Participate in clinical monitoring/project staff meetings and training sessions.
    • Audit Readiness: Provide guidance for audit readiness and support audit preparation and follow-up actions.
    • Mentorship: May mentor other Level 1 Site Monitors.

    Training and Education

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Proficiency in the local language preferred. English is required.

    Prior Experience

    • Minimum of 3 years’ experience as a clinical monitor with experience in virtual and onsite monitoring.
    • Experience managing complex and high-risk protocols.

    Technical Competencies

    • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
    • Proficient computer skills and ability to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage travel up to 75%.
    • Networking and relationship-building skills.
    • Effective communication with internal and external stakeholders.
    • Adaptability to changing technologies and processes.
    • Expertise in systems like Siebel CTMS, eTMF, and eISF (Florence).

    Why ICON?

    • Comprehensive and competitive total reward package including base pay, variable pay, and recognition programs.
    • Best in class employee benefits, supportive policies, and wellbeing initiatives.
    • Commitment to employee development in a continuous learning culture.
    • Equal opportunity and inclusive employer, free of discrimination and harassment.
    • Reasonable accommodation provided for medical conditions or disabilities during the application process or job performance.

    Encouragement to Apply

    • Interested but unsure if you meet all requirements? Apply regardless – you might be exactly what we’re looking for at ICON.

    This structured format organizes the information clearly and concisely, making it easier to understand the role and responsibilities of a Clinical Research Associate (CRA) at ICON.

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