Senior CRA / CRA II – Sponsor Dedicated

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    9 hours ago
  • Category:

**Job Overview**

Senior CRA position available to work on Oncology trials across phases I, II and III. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Portugal. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

+ Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets (6 per month)

+ The role can be home based or office based in Madrid.

+ Join a stable team of CRAs and benefit from outstanding training and development, both initially and throughout your career

+ Join a company where people tend to stay for 6-10 years rather than 1-3!

+ Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:

+ All aspects of site management as prescribed in the project plans

+ Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks

+ Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements

+ Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.

+ Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

**Education / Qualifications**

+ Life Science educational background

+ Master in Clinical monitoring

+ Fluent in both English and Portuguese


+ At least 2 years of independent monitoring experience in international trials.

+ Previous experience in monitoring Oncology protocols

+ Experience with SSU submissions

+ Experience in phases II and III

**Job Number** _2018-26491_

**Job Category** _Clinical Research Associates_

**Position Type** _Full-Time_

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.