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Clinical Research Associate - CNS - Italy

Employer: Worldwide Clinical Trials
Location: Rome, IT
Salary: Competitive
Start date: 27 Aug 2020
Closing date: 26 Sep 2020

Discipline: Clinical Research
Hours: Full Time
Contract Type: Permanent
Experience Level: Experienced (non-manager)

Job Details
Company

Job Details

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

Company

Find out more about working for our company

Brief Company Description;

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Company info

Website: https://www.worldwide.com/
Mini-site: Worldwide Clinical Trials
Telephone: +44 115 956 7711
Location: 1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom

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