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Job Details

Senior CRA (South East) - Perm or 12 month contract

Company: inVentiv Health Clinical
Location:
Reference: LJ17004854
Closing Date: 03 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

INC Research / inVentiv Health are working with a US based Start-up Biotech, whom are looking for a Sr CRA to focus solely on one phase I Psoriasis study

Requirements:

Ref/number: LJ17004854

Job title: Senior CRA

Location: South East / Home-counties

Home-based

Permanent

 

Summary:

 

INC Research / inVentiv Health are currently recruiting for a Senior CRA to be working on either a 12 month contract or permanent basis and will be directly insourced to single sponsor studies. The position offers the chance to work for a truly innovative biotechnology company focusing on a specific phase I Psoriasis study.

The successful candidate will need to be available to travel to Surrey on a regular basis for monitoring visits and will ideally be available to join us by January 2018.

We are considering applicants whom are available on both a full-time or 0.6-0.8 FTE basis. 

Work Here. Matters Everywhere.

 

Job Description

The   Senior   Clinical   Research   Associate   will   perform   clinical monitoring  activities following study guidelines, SOPs and applicable regulations. This position is responsible for ensuring the overall integrity of assigned studies through the use of independent judgement and expertise to assess adherence to study protocol and regulations.

  • Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements
  • Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training
  • Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations
  • Evaluate overall performance of site and site staff
  • Ensure compliance and understanding of study requirements by site staff
  • Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff
  • Interpret data to identify protocol deviations or major risks to data integrity
  • Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines
  • Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions
  • Review and verify case report forms and other clinical data for completeness and accuracy
  • Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations
  • Generate queries and manage resolutions with site staff
  • Maintain project tracking systems as required
  • Participate in the identification and selection of investigators and clinical sites
  • Assist in the development of study specific monitoring procedures and guidelines
  • Complete assigned training programs and apply learning
  • Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

 

 

 

 

 

Education and experience required

 

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Five years prior clinical monitoring experience, including Phase I experience and monitoring in the UK
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Must demonstrate good computer skills
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

Apply for this job: Senior CRA (South East) - Perm or 12 month contract

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
SL6 7AA, UK
England
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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