Clinical Research Associate - CNS - Italy

Employer
Worldwide Clinical Trials
Location
Rome, IT
Salary
Competitive
Closing date
26 Sep 2020

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
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SUMMARY: Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

RESPONSIBILITIES:
  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Assess, monitor, and train study site staff on protocol adherence as required
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems
  • Assist the site in maintenance of the Investigator Site File
  • Maintain regular communication with sites
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Assist sites in data query resolution
  • Ensure site compliance with IP receipt, accountability and return or destruction
  • Complete final site close out visit and report


OTHER SKILLS AND ABILITIES:
  • Good oral and written communication skills
  • Good planning and organizational skills with effective time management
  • Good interpersonal skills
  • Ability to work in an organized and methodical manner
  • Basic understanding of clinical research principles and process
  • Basic understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Basic knowledge of one therapeutic area, sufficient to function as a CRA
  • Good understanding of standard operating procedures
  • Basic knowledge of Microsoft Office
  • Familiarity with IxRS, EDC systems


REQUIREMENTS:
  • Medical Doctor (MD) degree OR
  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
  • Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and one year experience with clinical research (e.g. study coordinator, CTA, etc.)
  • Willingness to travel required
  • Valid current passport required
  • Driving license required
  • Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English


#LI-KP1

Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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