CRA II (Central Poland) - Sponsor-dedicated

Employer
Syneos Health
Location
Poland (PL)
Salary
negotiable
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
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Clinical Site Monitor II (CRA II)

Home-based

Central Poland

Permanent contract

Sponsor-dedicated

Job Details:

•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.

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

  • Minimum of a Bachelor of Science degree in a health related field with around 1,5 or 2 years clinical research experience
  • Previous proven experience in monitoring Oncology studies.
  • Demonstrated success in working independently
  • Strong communication and leadership skills
  • Ability to work independently and travel up to 50% of time.
  • Fluent in Polish and English.

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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