Senior CRA Home-based

SRG

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Job ID :

2235


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,Rome,Rome,


Key Skills :

SENIOR / CRA / Clinical monitoring / Home-based / Italy


Salary :

€35000.00 - €55000.00 per annum


Date Posted :

25 May, 2016



Company Name :

SRG


Location1 :

Rome




Job Category :

Clinical Monitoring Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

Negotiable,Upto 50%





Description

Senior CRA Home-based in Rome



COMPANY BACKGROUND

SRG Clinical is currently assisting in the recruitment of 1 Senior Clinical Research Associate in Rome, Italy. This is an excellent opportunity to work with a medium size clinical research organisation (CRO) and work with a variety of sponsors worldwide.

The individual will conduct monitoring visits at assigned sites, and will ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures and good clinical practice.

ROLE RESPONSIBILITIES

Working within a greatly experienced Clinical research team your responsibilities will include, but not be limited to:
* Perform site selection, initiation, monitoring and close out visits from Phase I - Phase IV
* Provide site management for a variety of protocols, sites and therapeutic areas
* Manage protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
* Tracking regulatory submissions and approvals, recruitment and enrolment, case report form completion and submissions
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports
* Preparing and conducting pre-study activities, site selection, initiation visits, routine monitoring and close-out visits
* Performing feasibilities
* Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities
* Planning and participating at Investigator's meeting(s)
* Responsible for the site(s) and on-site management during the study process
* Ordering and coordinating study supplies
* Preparing study documentation and assisting the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site
* Negotiating contracts with the clinics, local/central laboratory(ies)/pharmacy etc.
* Responsibility for the final archiving of all study documentation in-house
* Lead CRA role i.e. support Project leader in the coordination of project activities of CRAs
* Mentoring of junior CRAs

SKILLS and experienced DESIRED

* Minimum 24-months experience as a senior CRA role
* At least 4 full years' experience as a CRA including all steps of the clinical study; i.e. site initiation, site monitoring and site closure for SCRA positions
* On-site monitoring experience
* Ethics submissions in Italy
* Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
* Excellent organisation and time management skills with a proven ability to meet deadlines.
* Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of Microsoft
* Fluency in English and Italian

HOW TO APPLY?

Please contact Arnaud Heroult on +44 (0)203 096 4712 or email arnaud.heroult@srgclinical.com if you would like to know more about this opportunity.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.


Company Name:

SRG


Headquarters:

9 Devonshire Square,


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC2M 4H


Website:

www.srg.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

+44 (0) 203 096 47 0


For more information,visit www.srg.co.uk.

View all SRG Jobs



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