Clinical Research Associate II job in Poland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Research Associate (CRA)

Location: Poland

This vacancy has now expired. Please see similar roles below...

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

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