Senior Clinical Research Associate - Global CRO - Home/Office B

SRG

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Job ID :

4090


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Eastern Europe,Prague,Prague,


Key Skills :

Clinical research associate | clinical research | clinical monitor | monitoring | pharma | pharmaceu


Salary :

€0.00 per annum


Date Posted :

20 Sep, 2016



Company Name :

SRG


Location1 :

Prague




Job Category :

Clinical Monitoring Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

Negotiable,Upto 50%





Description

Senior Clinical Research Associate (SCRA) - Global CRO - Home based/Office Base- Czech Republic - Salary to be determined

Are you a rigorous Senior Clinical Research Associate with experience for a CRO or a pharmaceutical company and willing to grow your career?

COMPANY BACKGROUND

My Client is a global CRO seeking to add 1 SCRA to their expanding clinical monitoring team in Czech Republic for their Oncology Business Unit, to be based in either our Prague office or home-based.

ROLE RESPONSIBILITIES

Working within a friendly 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
* Act as mentor for clinical staff including co-monitoring and training visits
* 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

SKILLS DESIRED

* Minimum 18-months experience (required by law) as a senior CRA role (Phase I-IV), ideally included trials in Oncology.
* At least 4 full years' experience (required by law) as a CRA including all steps of the clinical study; i.e. site initiation, site monitoring and site closure
* Solid On-site monitoring experience
* Life-science degree
* Basic understanding of SOPs, WIs, FDA, local regulations and ICH GCP guidelines
* Excellent organisation and time management skills with a proven ability to meet deadlines

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.

KEYWORDS:
Clinical research associate | clinical research | clinical monitor | monitoring | pharma | pharmaceutical | study monitoring | clinical studies | pharmaceuticals | biotech | cro | pharma |. ICH-GCP | Regulatory submission |

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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