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Cra Ii - Argentina Home Based

2+ years
Not Disclosed
10 Dec. 1, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

The Clinical Research Associate II (CRA II) position at Syneos Health is a home-based role based in Argentina. This role focuses on clinical trial monitoring, site management, and ensuring compliance with regulatory standards such as ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and other relevant guidelines.


Position Overview

  • Location: Home-Based, Argentina
  • Job ID: 24006459
  • Updated: November 27, 2024

As a CRA II, you will manage various aspects of site monitoring, including site initiation, interim monitoring, close-out visits, and ensuring proper documentation. The position requires expertise in clinical data management, adherence to regulatory requirements, and strong communication with study site personnel.


Key Responsibilities

  1. Site Monitoring and Management:

    • Perform site qualification, initiation, monitoring, and close-out visits (both on-site and remotely).
    • Ensure compliance with protocols, ICH-GCP, and regulatory guidelines.
    • Evaluate site performance and communicate/escalate serious issues, providing action plans.
  2. Clinical Data Integrity:

    • Review source documents and verify accuracy and completeness of Case Report Forms (CRFs).
    • Resolve queries on clinical data and guide site staff as necessary.
  3. Investigational Product (IP) Management:

    • Oversee IP inventory and ensure appropriate labeling, storage, dispensing, and security.
    • Apply knowledge of GCP/local regulations to ensure IP compliance.
  4. Documentation:

    • Review the Investigator Site File (ISF) and ensure it is timely, accurate, and complete.
    • Ensure proper archiving of essential documents according to local guidelines.
  5. Site Support and Communication:

    • Act as the primary liaison between the study site and the project team.
    • Support patient recruitment and retention strategies.
  6. Audit Readiness:

    • Guide sites towards audit readiness and assist in preparing for audits.
  7. Real World Late Phase Studies (for some roles):

    • Provide support for site activities across the study lifecycle, from site identification to close-out.
    • Collaborate with medical science liaisons and local affiliates for real-world late-phase studies.
  8. Travel and Training:

    • Travel up to 75% for site visits and meetings.
    • Participate in investigator meetings and training sessions.

Qualifications

  • Education:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
  • Experience:

    • Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
    • Minimum of 2 years of experience as a CRA.
  • Skills:

    • Proficiency in using new technologies and clinical monitoring tools.
    • Strong communication, presentation, and interpersonal skills.
  • Travel Requirements:

    • Willingness to travel up to 75% for site monitoring activities.

Why Syneos Health?

Syneos Health values diversity, career development, and a supportive work culture. They aim to be a place where people can authentically be themselves, promoting innovation and teamwork to accelerate the delivery of therapies.


Application Information

If you meet the qualifications and are interested in working in a fast-paced and innovative environment, Syneos Health encourages you to apply for the CRA II role in Argentina. This is an excellent opportunity to contribute to impactful clinical trials while working remotely from home.a