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
Website: Achieva Group Limited
- Posted: 24th June 2022
- Expires: 22nd July 2022
