CRA (Clinical Research Associate) από Εταιρεία στη Θεσσαλονίκη

Η εταιρεία με την επωνυμία ΙΑΤΡΙΚΗ ΕΡΕΥΝΑ ΚΑΙ ΚΑΙΝΟΤΟΜΙΑ Ε.Ε. που εδρεύει στη Θεσσαλονίκη αναζητά CRA (Clinical Research Associate) για μόνιμη συνεργασία.

Experience/ qualification/ skills:

Experience with interventional clinical trials and extensive knowledge of ICH-GCP requirements
Excellent computer literacy with the MS Office Suite
Communication skills
Project management skills required, including ability to identify potential issues and proactively manage them to resolution.
Excellent knowledge in English and Greek language (verbal and written)
PhD, or Masters, or Bachelor΄s Degree in Health Sciences
Driving licence and availability to travel on a regular basis.
Responsibilities:


Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
Site management to ensure proper adherence to protocol, source data verification and assess CRF entries Develop, review and edit clinical trial related documentation including: Clinical/Study Protocol, Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
Assist with study protocol design, development and / or review if required
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
Perform pre-study initiation, interim monitoring and close out visits as required
Carry out drug formulation administration procedures and documentation records
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
Organise / attend investigator meetings as required
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV) discussing results with a medical statistician, who usually writes technical trial reports archiving study documentation and correspondence preparing final reports and occasionally manuscripts for publication.


Αποστολή βιογραφικών: [email protected] Linkedin Ιδρυτή: http://gr.linkedin.com/pub/panagiotis-panos-stafylas/42/77a/36b