CRA General Medicine in Poland

Employer
Syneos Health
Location
Poland
Salary
Competitive
Closing date
16 Oct 2020

View more

Discipline
Clinical Research, Clinical Operations, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

Here at Syneos Health we are currently recruiting for a Clinical Research Associate II to join our General Medicine team in Poland.

 

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 BMS 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, BMS 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.

 

Qualification requirements:

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Minimum 2 years` of experience in independent monitoring
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Experience in monitoring dermatology studies will be an asset
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 50% on a regular basis

 

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.

#LI-MŚ1

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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert