Associate Clinical Research - 422 - FH

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 (0) or email