Syneos Health

CRA II / Sr CRA - Oncology - Poland

Location
Home Based, POL
Salary
Competitive
Posted
20 Mar 2021
Closes
18 Apr 2021
Ref
20008825
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Clinical Research Associate to join our Oncology team in Poland.

This person will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.

Main Responsibilities:
  • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
  • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable Client SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
  • Ensures quality of data submitted from study sites and assures timely submission of data.
  • Ensures safety and protection of study subjects according to the monitoring plan, Client SOPs, and ICH and/or FDA GCP Guidelines.
  • Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
  • Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
  • Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
  • Appropriately escalates serious or outstanding issues to line manager and project team members.
  • Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
The ideal candidate will need the following experience / skills to be considered:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Minimum 2 years of independent monitoring experience
  • Experience in monitoring oncology studies required
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Demonstrated success in working independently
  • Strong communication and leadership skills
  • Fluent in Polish and English.

If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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