Location: Croatia
Job Ref: ZA/HQ00007929
An exciting opportunity has arisen to join a leading global Contract Research Organisation as Clinical Research Associate (all levels) in Croatia on a three month contract carrying out monitoring responsibilities in Croatia.
The purpose of the job will be to
Identify, select, initiate and close-out appropriate investigational sites for clinical studies.
Monitor those sites in order to ensure that studies are carried out in accordance with the study protocol and in accordance with SOPs/WPs applicable regulations and the principles of ICH-GCP.
Job functions and responsibilities include
Knowledge of the company's SOPs/WPs, ICH-GCP and appropriate regulations.
Recruitment of investigators.
Independent coordination of all the necessary activities required to set up and monitor a study, including
Identify investigators.
Preparation of regulatory submissions.
Design of patient information sheets and consent forms.
Coordinate documents translation, verification and back translations where required.
Ensure timely submission of protocol/consent/Safety reports documents for ethics/IRB approval.
Pre-study and initiation visits.
Conduct regular monitoring visits in accordance with the site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate
Maintain all files and documentation pertaining to studies.
Complete accurate study status reports.
Ensure the correct storage of drugs and the accurate account of all drugs in accordance with SOPs.
Keep the project manager regularly informed.
Process case record forms to the required quality standards and deadlines.
Participate in feasibility studies for new proposals, as required
Ensure the satisfactory close-out of investigator sites.
Ensure correct archiving of files on completion of a study.
Maintain patient and sponsor confidentiality
Participate in mentoring new staff.
Qualifications and experience
Medical/science background and relevant experience.
Ability and willingness to travel at least 50% of the time.
Ability to review and evaluate clinical data.
Computer literate.
Fluent English and Croatian.
Current full driving licence essential.
Good oral and written communication skills.
For further information please contact
Alina Lapadatu
Email: alina.lapadatu@hayspharma.com
Services advertised by Hays Pharma are those of an Agency and/or an Employment Business
This job was posted 30+ days ago, and has expired.
