Clinical Research Associate II

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. Poland
Posting date: 31 Mar 2021

An exciting home-based opportunity has arisen in Poland for a Senior and experienced CRA.This role includes performs monitoring to ensure that the rights and well-being of human subjects are protected.The Sr. CRA ensures that reported study data are accurate, complete and verifiable from source documents; and that the conduct of the study is in accordance with the currently approved protocol, SOPs, GCP/ICH Guidelines and other applicable regulatory requirements.

Job Responsibilities:

  • Prepare and complete applications to the regulatory authority and ethics committees.

  • Select and negotiate contracts with 3rd party providers.

  • Prepare Clinical Management Plan.

  • Prepare instructions to investigators and other site study staff.

  • Perform routine site visits, including selection, initiation, interim and closure

  • Manage assigned sites throughout the study by regular contacts to ensure site compliance, adequate enrolment, and understanding of study requirements.

  • Report to the project team line management, Sponsor and Investigator any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines.

  • Support project management team with assessment of workload and site assignments within the project team.

  • Assist with company's quality control initiative.

  • Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.

  • Participate in feasibility studies.

  • Assist with company's quality control initiative.

  • Participate in the interview process of potential candidates when required.

  • Participate in company-required training/conference programs.

Skills and Requirements

  • Bachelor or Master's degree in life sciences, pharmacy or nursing.

  • Preferably a minimum of 4 years of clinical research experience in the Pharmaceutical/CRO industry (including site initiation, monitoring and site closure).

  • Experience of Clinical Trial Project Management.

  • Strong knowledge of GCP/ICH Guidelines and other applicable regulatory requirements.

  • Experience of training and educating junior CRAs.

  • Strong knowledge of ICH Guidelines and other applicable regulatory requirements (including GCP refreshment course every other year).

  • Be aware of the commercial value of the performance.

  • Be accurate and have a high level of quality conscious.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities withinmajor pharmaceutical and medical device companies.