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Clinical Safety Specialist

Spain   •  €30 - €40 per hour  •  Contract/Temporary, Full time


Title: Clinical Research Specialist / Clinical Safety Specialist
Remote: Fully remote candidates considered (EMEA based candidates are open for this role)
Hours:  32- 40 hours 
Duration: 24 months 

Description:

  • 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 centres 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+ years safety experience (preferred)

SPECIALIZED KNOWLEDGE REQUIRED

  • Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
  • Affinity for data: logic statements, data visualization
  • Fluent with medical terminology

DESIRED/PREFERRED QUALIFICATIONS (optional)

  • Health professionals including Biomedical Engineer, Biomedical Scientist, RN, PA (Interested in biomedical engineers, RNs (BSNs), paramedics, etc.)
  • Experience with Business intelligence tools (Spotfire, Business Objects, Power BI, etc.) and SharePoint environments
  • While Cardiac experience would be nice, we don?t need any clinical trial experience (Exposure to clinical trials and cardiac experience is a plus)

Nice to Have's

    • Medical background (biomedical engineer, allied health professional, nursing, etc.)

 
Good to Have's 

  • Top three skills: Experience with Excel/logic statements, previous Safety experience would be a plus, proactive. Affinity for data: logic statements, data visualization

For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: RU-119-2
  • Posted: 5th January 2023
  • Expires: 2nd February 2023

Achieva Group Limited

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