Temat: Call for CRA (study start up in Poland)

German CRO located in Berlin looking for experienced CRA in Poland for start-up of a phase III study in orthopedics. We intend to recruite 10+ patients in 2 investigational sites in Poland.

Overview

The Clinical Research Associate will be a freelancer working independently and proactively to coordinate all necessary activities required for setting up and monitoring a phase III clinical trial in Orthopedics, completing accurate study status reports and maintaining study documentation.
The CRA will be required to coordinate, manage and facilitate the activities related to preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.

Main activities and tasks:
•Facilitate study start up, site feasibility and other activities
•Primary contact with investigative sites during start-up activities
•Identify potential investigators in collaboration with the Project Manager
•Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites
•Facilitate preparation and collection of site level documents
•Review, prepare and negotiate site contracts and budgets with sites
•Processing of all relevant issues of the ethics committees and regulatory authorities in adherence to the timelines
•Preparation of all the documentation required to start a clinical trial (communication to the Ethics Committee, Health Authorities etc.)
•Perform regulatory and ethics committee submission
•Liaise with project manager, investigative site personnel, legal office and sponsor.
•Actively identifies and address quality and compliance concerns
•Properly maintain the Trial Master File to be audited at any time
•Undertake other reasonably related duties as may be assigned from time to time

Role requirements
•A degree in scientific or health care discipline preferred
•At least 3 years experience in clinical research
•Experience and/or understanding of clinical study start up requirements and activities
•Excellent written and spoken English and local language
•Ready to take over responsibility, pro-active way of working
•Ability to work independently and to effectively prioritize tasks
•Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
•Effective communication, organizational, planning and interpersonal skills
To be considered for this opportunity or find out more please forward a CV as soon as possible to the address given below. Due to a high volume of applicants, only shortlisted candidates will be contacted.

Contact
Felix Cifire

T +49 30 230 809 48
Felix.Cifire@csg-germany.com