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Associate Clinical Research - 422 - FH

Bulgaria   •  €25 - €32 per hour  •  Contract/Temporary, Full time


We are currently recruitng for an Italian based Clinical Research Associate to join my client on an initial 2 year contract basis.

You will ideally have the following experience:

1. Registered Nurses preferred (entry level can be considered), and also interested in candidates with a Medical Doctor degree
2. Medical background (Dr., nurses, allied health professional, biomedical engineer, etc.)
3. Exposure to clinical trials and cardiac experience is a plus 

Description:

Top three skills: Previous Safety experience would be a plus, quick learner, proactive.

While Cardiac experience would be nice, we don?t need any clinical trial experience.

  • Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
  • Conduct Case Management in the Clinical Safety Database.
  • Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
  • Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies).
  • Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
  • Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).
  • Liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
  • Write Clinical Safety plan for assigned protocol(s).
  • Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
  • Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
  • Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.
  • Performs other duties as assigned.

BASIC QUALIFICATIONS:

  • Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
  • Proficient with MS Office products, word processing, spreadsheets, etc.
  • High attention to detail and accuracy and ability to manage multiple tasks.
  • Good prioritization and organizational skills.
  • Excellent problem solving skills.
  • Flexible and dependable.
  • Works effectively on cross-functional teams.

EDUCATION REQUIRED:

  • Bachelor?s degree


YEARS OF EXPERIENCE:

  • 2+ yrs safety experience (preferred)

SPECIALIZED KNOWLEDGE REQUIRED:

  • Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
  • Fluent with medical terminology

DESIRED/PREFERRED QUALIFICATIONS (optional):

  • MD, RN, PA or allied health professional including Biomedical Engineer, Biomedical Scientist, will work on Cardiac device trials

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: BH-32657
  • Posted: 24th June 2022
  • Expires: 22nd July 2022

Achieva Group Limited

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