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Sponsor Dedicated Cra Ii - Home Based Ita

2+ years
Not Disclosed
10 Dec. 1, 2024
Job Description
Job Type: Full Time Remote 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 Sponsor Dedicated Clinical Research Associate II (CRA II) position at Syneos Health is a home-based role located in Italy. This position is responsible for managing site monitoring activities for clinical trials, ensuring compliance with regulatory guidelines, and collaborating with cross-functional teams to support project success.


Position Overview

  • Location: Home-Based, Italy
  • Job ID: 24006483
  • Updated: November 27, 2024

As a CRA II, you will perform site qualification, initiation, interim monitoring, site management, and close-out visits. You will also be responsible for ensuring adherence to Good Clinical Practice (GCP), regulatory requirements, and the protocol. The role requires extensive communication and coordination with study sites, project teams, and stakeholders to ensure the timely and compliant execution of clinical trials.


Key Responsibilities

  1. Site Management:

    • Perform site qualification, initiation, monitoring, and close-out visits (both on-site and remotely).
    • Ensure that sites comply with regulatory, GCP, and protocol requirements.
    • Evaluate site performance and provide recommendations for corrective actions.
  2. Clinical Data Management:

    • Verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
    • Resolve queries and ensure data quality and integrity.
  3. Investigational Product (IP) Management:

    • Oversee IP inventory, reconciliation, and ensure proper handling, labeling, and dispensing in accordance with the protocol.
    • Ensure compliance with local regulations regarding IP management.
  4. Documentation and Compliance:

    • Review Investigator Site Files (ISF) for accuracy and completeness.
    • Ensure compliance with archiving requirements and local regulations.
    • Document all activities through confirmation letters, follow-up reports, and other project documents.
  5. Site Support and Liaison:

    • Serve as a liaison between study sites and the project team, ensuring smooth communication.
    • Provide guidance on site processes, recruitment strategies, and audit readiness.
  6. Real World Late Phase Studies (for some roles):

    • Support site activities across the study lifecycle, from identification through close-out.
    • Engage in chart abstraction, data collection, and collaboration with sponsor affiliates and local staff.
  7. Travel and Training:

    • Travel up to 75% of the time for site visits and project-related meetings.
    • Prepare for and attend investigator meetings and sponsor meetings.

Qualifications

  • Experience:

    • Minimum of 2 years of experience as a Certified CRA (according to M.D, 15 Nov 2011).
    • Experience in clinical monitoring, site management, and adherence to regulatory guidelines.
  • Skills:

    • Strong understanding of GCP/ICH guidelines, and local regulatory requirements.
    • Good computer skills and the ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage time and prioritize multiple tasks effectively.
  • Travel:

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

Why Syneos Health?

Syneos Health offers a dynamic and supportive work environment that fosters career development and progression. With a focus on collaboration and innovation, Syneos Health is committed to providing opportunities for growth and recognizes the importance of diversity in the workplace.


Application Information

This CRA II role offers an exciting opportunity to contribute to the success of clinical trials in an agile and supportive environment. If you meet the qualifications and are interested in working with Syneos Health, you are encouraged to apply.