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Job Details

Freeelance Senior/CRA- France

Company: ProClinical Ltd
Location: France
Reference: CR.TS.10451
Closing Date: 26 Jan 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Our client, a leading global CRO is seeking a Senior CRA/ CRA to join their team. The organisation specialises in the pharma and biotech sectors and is headquartered in the US, employing over 5,000 people worldwide. This is a contract position based in France. ...

Requirements:

Our client, a leading global CRO is seeking a Senior CRA/ CRA to join their team. The organisation specialises in the pharma and biotech sectors and is headquartered in the US, employing over 5,000 people worldwide. This is a contract position based in France.

Job Role:

  • Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. 
  • Provides clinical and technical support for Clinical Research Associates (CRA) I, II, and III and administrative staff. 
  • Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. 
  • May assume the role of a Lead CRA (LCRA) on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader.

Job Responsibilities:

  • Routinely anticipates/identifies potential issues and implements corrective actions independently. 
  • Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
  • Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. 
  • Participates in TMF and on-site audits as requested.
  • Responsible for site management and site staff performance including: monitors all types of clinical trials. Participates in all types of site visits, assures compliance with all protocol requirements, assures effective patient identification and recruitment plan is in place
  • Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
  • Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. 
  • Maintains awareness of key study performance indicators for own sites
  • Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. 
  • Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.

Education, Skills and Experience:

  • BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. 
  • Extensive clinical monitoring experience. 
  • Demonstrates extensive understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an advanced understanding and application of applicable therapeutic standards. 
  • Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. 
  • Effective command of written and spoken local language, if not English, as well as English. 
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment. 
  • Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Freeelance Senior/CRA- France

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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