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Job Details

Freelance Senior CRA - Spain

Company: Premier Research
Location: Madrid, Spain or home based in Spain
Reference: 941CR
Closing Date: 23 Apr 18
Type: Contract
Salary (£): Competitive
Benefits: Not applicable

Job Summary:

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Requirements:

We’re looking for a talented and energetic Freelance Clinical Research Associate to join our team in Spain. We require 0.5 FTE and availability to start immediately. The contract will be for 3 - 6 months.

Imagine. Inspire. Innovate. Impact. With Us.

You’ll be accountable for:

  • Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
  • Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
  • Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
  • Working with the line manager and CM to ensure that visit metrics are maintained as required.
  • Providing accurate and timely trip reports and records of hours worked.
  • Maintaining the project tracking system of subjects and site information.
  • Participating in Investigators’ Meetings as assigned by Project Managers.
  • Maintaining contact with investigator sites via telephone calls between visits.
  • Ensuring adherence to study timelines and budgets.
  • Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
  • Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.
  • Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
  • In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
  • Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.

Apply for this job: Freelance Senior CRA - Spain

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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